Articles in "Production Management"

Collegium Pharma gets USPTO notice of allowance for patent covering Oxycodone DETERx drug delivery technology

The US Patent and Trademark Office (USPTO) has issued Notice of Allowance to Collegium Pharmaceutical's patent application "Abuse-Deterrent Drug Formulation" US Patent Application Number 12/823,628. This will be the third issued patent related to the

Cost of Diabetes Care in U.S. Keeps Climbing

The total cost of diabetes in the United States jumped from $174 billion in 2007 to $245 billion in 2012 Last year's total cost included $176 billion in direct medical costs -- such as hospital and emergency care, medications and office visits -- an

Ranbaxy recalled lipitor in US market

Ranbaxy Pharmaceuticals Inc. has recalled dozens of lots of its generic version of cholesterol drug Lipitor because some may contain tiny glass particles, the latest in a string of manufacturing deficiencies that once led U.S. regulators to bar im

USFDA First-Time Generic Drug Approvals - June 2012

Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 ARMODAFINIL TABLETS50 MG150 MG250 MG MYLAN PHARMACEUTICALS, INC. NUVIGIL TABLETS 6/1/2012 2 ADAPALENE GEL,0.3% TOLMAR INC. DIFFERIN GEL, 0.3% 6/14/2012 3 ABACAVIR TABLETS USP,300 MG

FDA approved the first generic versions of Boniva (ibandronate) tablets

The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause. The most common type of bone disease, osteoporosis, is

International Ayurveda Foundation urges govt to include Ayush streams in NCHRH

International Ayurveda Foundation urges govt to include Ayush streams in NCHRH The International Ayurveda Foundation (IAF) has asked the government to reconsider the National Commission for Human Resources in Health (NCHRH) Bill to include the Ayush

Hospira to Acquire Active Pharmaceutical Ingredient Manufacturing and R&D Facilities

Hospira INC, the world's leading provider of injectable drugs and infusion technologies, today announced an agreement for Hospira to acquire an active pharmaceutical ingredient (API) manufacturing facility, together with an associated research and de

Ranbaxy Laboratories launches cholesterol reducing drug in 3 European countries

Ranbaxy Laboratories launches cholesterol reducing drug in 3 European countriesRanbaxy Laboratories, has announced launched generic versions of Atorvastatin tablets, used for the treatment of cholesterol, in three European countries Italy, Sweden and

Increase health care allocation to 2.5% of GDP: Dr Reddy's

At least 2.5 per cent of the country's GDP in the forthcoming Budget should be allocated on improving health care, says Dr Reddy's Laboratories, India's second largest drug maker."Time has now come to incentivise and encourage the penetration of heal

US FDA approves labelling update for Merck's Isentress

The US Food and Drug Administration (FDA) has approved a labelling update for Merck's, known as MSD outside the United States and Canada, Isentress (raltegravir) film-coated tablets to include 156-week data from the STARTMRK study with Isentress in c

Hearing on Novartis’ case on Sec 3(d) of India's Patents Act in SC to be delayed

Hearing on Novartis’ case on Sec 3(d) of India's Patents Act in SC to be delayed he hearing on Novartis' case on Section 3(d) of India's Patents Act in Supreme Court is likely be delayed from 28 February to sometime in March as the Mumbai terror atta

WHO approves India's vaccine regulatory system

In a major relief to vaccine industry, the World Health Organization has approved India's vaccine regulatory system for maintaining international standards. This step opens the way for easy export of vaccines produced in the country.The WHO team of i

Bayer challenges Nexavar generic licence order

Drugmaker Bayer has filed an appeal against an Indian Patents Office's order , which allowed domestic drug maker Natco Pharma to sell a generic version of the German firm's cancer drug 'Nexavar' in India, with the Intellectual Property Appellate Boar

FDA announces safety changes in labeling for some cholesterol-lowering drugs

Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration. These products, when used with diet and exercise, help to lower a person's

Biosimilar products development gets a USFDA norms boost

Biosimilar products development gets a USFDA norms boost ​But they form the basis for Indian companies to attack a market that would open up by 2015 and could reach $11 billion by 2020. A biosimilar is a product that is similar to a biologic, which i

Ranbaxy Laboratories Trie, in preparation for the upcoming U.S. launch of the product through its dermatology sales force

Ranbaxy Laboratories Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), today announced that the U.S. Food and Drug Administration (FDA) has approved Absoriea™ a novel, patented brand formulation of the acne medication isotr

US drugmaker Pfizer scraps insulin deal with Biocon

US drugmaker Pfizer scraps insulin deal with Biocon ​ USdrugmakerPfizersaid on Monday it has scrapped a deal to sellinsulin productsmade byBiocon Ltd, in what is set to be a major blow for India's largest listed biotech firm.The companies did not say

Global drug industry tightens anti-corruption code

Global drug industry tightens anti-corruption code Ben HirschlerThe global pharmaceutical industry is tightening its code of practice in a bid to stamp out bribery and corruption, particularly in emerging markets.The International Federation of Phar

FDA Finds Serious Problems in Cancer Drug Factory

FDA Finds Serious Problems in Cancer Drug Factory Federal inspectors say the contract manufacturer for Johnson Johnson's cancer drug Doxil hasn't been maintaining equipment or promptly investigating defective product batches and other serious proble

India’s Supreme Court to Hear Dispute on Drug Patents

India’s Supreme Court to Hear Dispute on Drug Patents While China was becoming the world’s shop floor, India took its place as the world’s pharmacy, and in recent decades has been the largest provider of cheap, lifesaving medicines in poor countries

US FDA issues draft guidance on biosimilar product development

US FDA issues draft guidance on biosimilar product developmentThe US Food and Drug Administration (FDA) issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “Whe

European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections

European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on insp

Dr. Reddy's Announces the Launch of Ropinirole Hydrochloride XR (Extended-Release) Tablets

Dr. Reddy's Laboratories announced today that it has launched Ropinirole Hydrochloride XR (Extended-Release) tablets (2 mg, 4 mg, 6 mg, 8mg, and 12 mg), a bioequivalent generic version of REQUIP XL (R) tablets in the US market on June 06, 2012 follow

Regulatory issues cost high, Ranbaxy Takes Q4 Loss

Regulatory issues cost high, Ranbaxy Takes Q4 Loss Indian drug manufacturer Ranbaxy Laboratories, still reeling from a $500 million fine paid for regulatory violations, announced on 24 February that it would suffer a $607 million loss despite increas

Glenmark recalls seven lots of Norgestimate and Ethinyl Estradiol tablets

Glenmark recalls seven lots of Norgestimate and Ethinyl Estradiol tablets Glenmark Generics has announced a consumer-level recall of seven lots of Norgestimate and Ethinyl Estradiol tablets USP, 0.18mg/0.035mg, 0.215mg/0.035mg, 0.25mg/0.035mg, becaus

Remove barriers to help exports, India urges Indonesia

Remove barriers to help exports, India urges IndonesiaUnion Minister for Commerce Industry and Textiles Anand Sharma has urged Indonesia to improve its offer on services and remove the non-tariff trade barriers that are discouraging India’s exports o

EU sets out tough rules on medicines information

EU sets out tough rules on medicines information PICTURE GALLERY (Reuters) - Europe will strictly limit the amount of information that drug makers can supply to the public on prescription-only medicines and retain a ban on advertising under proposed

Strides acquired star drug

Drug firm Strides Arcolab today said its subsidiary Agila Specialities has acquired a US health regulator-approved facility in Tamil Nadu from Star Drugs and Research Labs Ltd for about Rs 125 crore. As part of its well articulated strategy to build

Drug price control does not help consum

Drug price control does not help consumer Every time the problem of poor healthcare access in India is discussed and solutions sought, ‘price control' of medicines seems to be an automatic choice for many stakeholders.Conveniently forgotten is the f

Exempt all life saving drugs from GST

Exempt all life saving drugs from GST The Indian Pharmaceutical Industry employs over 4.2 million personnel, both in manufacturing and ancillary sectors. India is ranked 3rd largest country in terms of production volume and 14th in terms of value wit

Department of Pharmaceuticals to consider industry feedbacks before finalizing new pricing policy

Department of Pharmaceuticals to consider industry feedbacks before finalizing new pricing policy ​ The new draft of the proposed National Pharmaceutical Pricing Policy (NPPP) has evoked a mixed response as far the official reactions are concerned.

A New Era in Pharmaceutical Innovation Means Major Challenges for the Industry

A New Era in Pharmaceutical Innovation Means Major Challenges for the IndustryThe value generated by a dollar invested in pharmaceutical research and development has fallen by more than 70 percent in recent years, according to a new study from the co

US FDA & medical device industry reach agreement in principle on user fees

US FDA medical device industry reach agreement in principle on user fees The U S Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third

Stronger Code of Practice for Global Pharma Industry

Stronger Code of Practice for Global Pharma Industry By Sten StovallDavid Brennan, CEO of AstraZeneca and president of the IFPMA, pictured last year.The world drugs industry is tightening its code of practice in an attempt to clamp down on corruption

Abbott to Separate in to Two Leading Companies in Diversified Medical Products and Research-Based Pharmaceuticals

Abbott to Separate into Two Leading Companies in Diversified Medical Products and Research-Based PharmaceuticalsAbbott (NYSE: ABT) announced that it plans to separate into two publicly traded companies, one in diversified medical products and the oth

Pfizer voluntarily recalls 28 lots of contraceptive tablets from US market

Pfizer voluntarily recalls 28 lots of contraceptive tablets from US market Pfizer Inc. has voluntarily recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets (generic)for cu

Mylan Launches Generic Version of Epivir® Film Coated Tablets in the UK and Italy, its First Generic ARV Launch in Europe

Mylan Inc. today announced that its UK and Italy-based subsidiaries have launched Lamivudine Film Coated Tablets, 150 mg and 300 mg. This product is the generic version of GlaxoSmithKline's Epivir® Tablets, indicated as part of antiretroviral (ARV) c

Stay on union health ministry's notification on six drugs (Banned) still valid

Stay of court on union health ministry's notification on six drugs still valid The stay on the notification of the Union Health Ministry for banning the marketing of six controversial drugs is still valid until any verdict comes from the Madras High

Lilly launches mobile application for oncology healthcare professionals

Eli Lilly and Company has launched a searchable clinical trial mobile application for oncology healthcare professionals. The app — available for Apple iPad and iPhone, as well as RIM's BlackBerry and Google's Android platforms — allows healthcare

'Gray' Drug Marketer Again Under Scrutiny

'Gray' Drug Marketer Again Under Scrutiny A congressman for a second time is demanding a drug wholesaler answer questions about its handling of one of many lifesaving hospital drugs whose shortages have been disrupting patient care and leading to de

US FDA approves Stiefel's Fabior Foam, 0.1% to treat acne

The US Food and Drug Administration has approved Stiefel's, a GSK company, New Drug Application for Fabior (tazarotene) Foam, 0.1 per cent. It is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients 12 years

2011 will be a year of regulatory tussle for pharmaceutical industry

2011 will be a year of regulatory tussle for pharmaceutical industry Government policy and regulatory changes were the focus point for thepharmaceutical industryin Indiain the year2011. The government actively intervenedin businessand sought more con

US DOJ files consent decree on Ranbaxy

US DOJ files consent decree on Ranbaxy TheUS Department of Justicehas filed a consent decree in the districtcourt of Maryland for the Indian pharmaceutical major, Ranbaxy aiming to resolve the four-year long investigation by the US Food and Drug Adm

Aurobindo Pharma receives final approvals for Quetiapine Fumarate Tablets

Aurobindo Pharma Limited is pleased to announce that the company has received final approvals from the US Food Drug Administration (USFDA) to market Quetiapine Fumarate Tablets 25mg, 50mg, 100mg, 150mg, 200mg, 300mg and 400mg (ANDA 091388) Queti

Centre releases 'National Policy on Narcotic Drugs and Psychotropic Substances'

Centre releases 'National Policy on Narcotic Drugs and Psychotropic Substances' The central government has come out with a 'National Policy on Narcotic Drugs and Psychotropic Substances' (NDPS), under which the private sector companies will be allowe

Study Confirms Some Contraceptive Pills More Likely to Cause Blood Clots

Study Confirms Some Contraceptive Pills More Likely to Cause Blood ClotsA study published on bmj.com today confirms previous findings that certain oral contraceptive pills are more likely to cause serious blood clots (venous thromboembolism - VTE ) t

Indian Pharma Export Value: 2002, 2003, 2004, 2005

India's Export of Principal Commodities by Regions DRUGS, PHARMACEUTICALS FINE CHEMICALS S.No Region APR-2002- APR-2003- APR-2004- APR-2005- MAR-2003 MAR-2004 MAR-2005 MAR-2006 Rs. Crores Rs. Crores Rs. Crores Rs. Crores 1 Europe 2858.28 38

US FDA approves Perrigo's butoconazole nitrate 2% vaginal cream

Perrigo Company, a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, and APIs, has received final approval from the US Food and Drug Ad

DoP to give final shape to the National Pharmaceuticals Pricing Policy within three to four weeks

DoP to give final shape to the National Pharmaceuticals Pricing Policy within three to four weeks Apparently browbeaten by the apex court in the country, the Department of Pharmaceuticals (DoP) has decided to give a final shape to the National Pharma

Confusion prevails over status of six banned drugs as court is yet to deliver final verdict

Confusion prevails among the state drug authorities and the industry over the status of the union health ministry's notification dated 10/2/2011 in which it had banned six drugs including nimesulide for below 12 years of age and combination of PPA (p

Zydus Cadila has acquired 100% stake in Biochem

Zydus Cadila has acquired 100% stake in BiochemAhmedabad-based pharma major, Zydus Cadila, has acquired 100 per cent stake in Biochem, a Mumbai-based mid-sized drug company. Biochem has presence in therapeutic areas of antibiotics, cardiovascular, an

NPPA cuts down prices of vitamin C, revises rates of 183 formulation packs

The National Pharmaceutical Pricing Authority (NPPA) has slashed the prices of widely-used bulk drug vitamin C and its derivatives, while raising the price of another bulk drug parachlorometaxylenol (PCMX) and revising the rates of 183 formulation pa

Natco Pharma bags licence to sell Bayer's cancer drug Nexavar

Natco Pharma bags licence to sell Bayer's cancer drug Nexavar The government has allowed a local drugmaker to make and sell a patented cancer drug at a fraction of the price charged by Germany'sBayerAG, setting a precedent for more such efforts by In

Ranbaxy resume US export after 4 Year

We recognise that Ranbaxy's most important challenge is finding a resolution to regulatory issues with the US authorities," wrote Joji Nakayama, president chief executive officer, Daiichi Sankyo, in the company's 2011 annual report. Forty-six mont

Patent office appoints 150 patent examiners to expedite process of patent examinations

Patent office appoints 150 patent examiners to expedite process of patent examinationsTo address the growing pressure from the increasing number of patent applications filed in the country, the Controller General of Patents, Designs and Trademarks re

Corrective action and preventive actioN (CAPA)

CAPA are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP). It focuses on the systematic investigation of the root ca

Facts: Indian Pharma Import

IMPORT OF MEDICINAL PHARMA PRODUCTS S.No Countries Apr 2004- Mar 2005 (Rs. crores) April 2005 - Mar-2006 (Rs. crores) 1 China P Rp 908.57 1563.53 2 Switzerland 375.44 547.35 3 U S A 298.11 425.32 4 Germany 188.82 276.33 5 Denmark 107.48 174.48 6 Ita

NCK Pharma Solution launches beta version of Pharma Dictionary version 1.2

NCK Pharma Solution Private Limited launches the Pharma Dictionary Version 1.2 ALL IN ONE for Pharmaceutical Professionals, students and educators. The unique is that the dictionary contains the terminologies across the industry from regulatory, prod

Biotech's Biggest R & D Spenders in 2011

Biotech's Biggest Spenders 2011If you add up the RD budgets for the top 15 public biotechs in the world, you'll find a tab that runs right about $10 billion. That's not small change, by any means, but to put it in some perspective, it is interesting

PCI to introduce new regulations for upgrading pharmacy eduction soon

PCI to introduce new regulations for upgrading pharmacy eduction soon With an aim to bring in strategic changes in the way pharmacy education is being imparted in the country, the Pharmacy Council of India (PCI) is soon planning to upgrade and bring

Lupin gets US FDA approval for Suprax capsules 400 mg

Lupin, a Rs. 6,950 crore plus pharma major, has received US FDA approval for Suprax (Cefixime) capsules 400 mg. The approval will expand Lupin's range of Suprax dosage forms available to treat the approved indications in appropriate patients. Supr

Pfizer Elects CEO Ian Read as Chairman of the Board

Pfizer Elects CEO Ian Read as Chairman of the Board Pfizer Inc. (NYSE: PFE) announced that its Board of Directors has elected current President and Chief Executive Officer, Ian Read, as Chairman of the Board and Chief Executive Officer, effective im

Ranbaxy ordered to improve India, US plants

Ranbaxy ordered to improve India, US plants US drug regulators have sought a "ground-breaking" injunction against Ranbaxy Laboratories to force the Indian drug major to correct long-standing violations at four of its manufacturing facilities. The c

India: A Pharmaceutical Superpower by 2020: IPC

India: A Pharmaceutical Superpower by 2020: IPCSubodh Priolkar, President of Indian Pharmaceutical Congress (IPC), talked about the seminar on “Vision 2020: India - The Pharma Power House” in the 63rdIPC conference held in Bangalore from 16th-18thDe

US FDA finalizing draft rules on data submissions to demonstrate bio-similarity to reference product

US FDA finalizing draft rules on data submissions to demonstrate bio-similarity to reference product US FDA may soon finalize a set of guidelines titled ‘Scientific considerations in demonstrating bio-similarity to Reference Product’. The draft guid

CDSCO plans to set up eight new central drug testing labs at Rs.320-cr

CDSCO plans to set up eight new central drug testing labs atRs.320-cr With controversies and apprehensions still keep surfacing about the quantum of spurious drugs, the Central Drugs Standard Control Organisation (CDSCO) is planning to set up more ce

USFDA: Abbreviated New Drug Application (ANDA) ApprovalsNovember 2011​

USFDA: Original Abbreviated New Drug Application(ANDA) ApprovalsNovember 2011​ Drug Name and FDA Appl. # Active Ingredients Marketing Status Company Approval Date TRANEXAMIC ACID (ANDA # 091657) TRANEXAMIC ACID Prescription BIONICHE PHARMA 11/0

FDA OKs first obesity drug in 13 years

U.S. health regulators approved the first new weight-loss drug in 13 years, allowing Arena Pharmaceuticals Inc to bring its Belviq pill to market as public health advocates push for new solutions to the nation's growing obesity epidemic. The Food an

Domestic pharma companies may get hit by DPCO

Domestic pharma companies may get hit by DPCO A recent report released by Fitch Ratings has predicted that 2012 will remain stable for the Indian pharmaceutical sector. However, there are hitches in the growth which has been clearly observed in the t

Established names of drugs from regulatory perspective

Drugs are often times known by various names which may be code names, chemical names, acronyms, innovator's names, trivial names, official names, compendial names and United States Adopted Names (USAN). Because of the number of drugs available, it i

Pfizer to lose crown to Sanofi as world’s biggest drug maker

Pfizer to lose crown to Sanofi as world’s biggest drug makerAfter nine years as the world’s biggest maker of medicines,Pfizeris set to cede its crown next year to a company that a decade ago few would have predicted to be leading the pharma league ta

Indian Pharma sector growth may slow down to 13% in 2011

Indian Pharma sector growth may slow down to 13% in 2011 The Indian pharma industry is expected to register subdued growth of 12-13% in 2011 due to weak macro factors and increasing competition from unlisted players and MNC pharma companies, an indus

APP Pharma acquires benztropine mesylate, levetiracetam & tranexamic acid injectables from Nexus Pharma

APP Pharmaceuticals, LLC, a Fresenius Kabi Company, has acquired benztropine mesylate injection, levetiracetam injection and tranexamic acid injection from Nexus Pharmaceuticals, Inc. Under terms of the agreement APP takes complete ownership of these

India to be among top 10 pharma markets by 2015: Ernst & Young report

India to be among top 10 pharma markets by 2015: Ernst Young report Emerging markets India and China will figure in the top 10 pharma markets of the world by 2015, an Ernst Youngreporthas said. The report has identified India as the preferred choi

Industry asks govt to hold back implementation of bar coding on secondary level packaging

Industry asks govt to defer implementation of bar coding on secondary level packaging Even as the second phase of bar code implementation expected to become effective from January 1, 2012 under which bar coding on secondary level packaging of pharma

What is biosmilar drugs?

Biosimilars or follow-on biologics are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars ar

Ranbaxy gets approval to launch generic Lipitor in US

Ranbaxy gets approval to launch generic Lipitor in US ​ Global drug major Ranbaxy Laboratories on Thursday announced the launch of its generic version of its much sought after cholesterol-lowering drug Lipitor in the U.S. market.The announcement of

Sales Skills for Non-Salespeople Using "Consultative Selling" to Pitch Your Idea or Product

Sales Skills for Non-Salespeople Using "Consultative Selling" to Pitch Your Idea or Product Are you trying to convince your manager to develop a new product, but can't get him or her to take things further? Or, would you like to introduce a new syste

Negative factors, economic slowdown seriously retard growth of Indian pharma: Dr MD Nair

Negative factors, economic slowdown seriously retard growth of Indian pharma: Dr MD NairEconomic downturn, reduced investments, high costs of RD and low productivity, patent cliffs, pressure on drug prices, poor image of the industry and stricter reg

We are Indian Pharmaceutical company. We want to know - What is the drug registration requirement of GCC countries?

The product approval is granted after a scrutiny of the following documents;Manufacturing license of the company;Certificate by Indian authorities for Good Manufacturing Practice (GMP);Product file of the particular product to be exported; andProduct

Four potential blockbusters in the Pharma pipeline: Bayer Pharmaceutical

Four potential blockbusters in the Pharma pipeline: Bayer Pharmaceutical ​The Bayer Group plans to continue investing heavily in research and development and expects its Pharmaceuticals business in particular to generate substantial sales with the ne

USFDA: Original New Drug Application (NDA and BLA) Approvals November 2011

USFDA: Original New Drug Application (NDA and BLA) Approvals November 2011 ​ Drug Name and FDA Appl. # Active Ingredients NDA Chem. Type* Review Classifi- cation** Company Approval Date XARELTO (NDA # 202439) RIVAROXABAN S JANSSEN PHARMA 11/

Aegerion Lomitapide drug found to treat hypercholesterolemia

Aegerion Lomitapide drug found to treat hypercholesterolemiaAegerion Pharmaceuticals has reported positive Phase III clinical study results of its Lomitapide drug, used to treat patient with homozygous familial hypercholesterolemia (HoFH).Lomitapide

Elder Pharma launches Zalain in association with Ferrer

Elder Pharmaceuticals Ltd, in association with the Spain based International Pharmaceutical company Ferrer announced the introduction of the Zalain (Sertaconazole), a topical treatment used to treat fungal skin infections for the first time in India.

NCK Pharma Solution Private Limited pharma training courses got Accredition by International Association of Distance Learning

"NCK Pharma Solution Pvt Ltd." now earned Accredited Membership status from INTERNATIONAL ASSOCIATION FOR DISTANCE LEARNING for its Advance Diploma and Certificate course. NCK Pharma Solution Private Limitedhas created a iconic training brand "Knowl

U.S. Nutraceutical Market Predicted to Generate 8% CAGR Through 2015

U.S. Nutraceutical Market Predicted to Generate 8% CAGR Through 2015 The world nutraceutical market is expected to reach more than $180 billion in 2017 due to the aging population, increased prevalence of serious diseases, and an enhanced focus on pr

USFDA: New Drug Application (NDA and BLA) Approvals December 2011

USFDA: New Drug Application (NDA and BLA) Approvals December 2011 ​ Drug Name and FDA Appl. # Active Ingredients NDA Chem. Type* Review Classifi- cation** Company Approval Date HYDROMORPHONE HYDROCHLORIDE (NDA # 200403) HYDROMORPHONE HYDROCHL

Counterfeit (Fake) drugs & new technology to identify It in India

Counterfeit (Fake) drugs new technology to identify It in India Making pills that could save lives both in India and abroad, Indian pharmaceutical companies are growing faster than ever before. Worth over $12bn, the Indian Pharma industry is expecte

Reckitt Benckiser Pharmaceuticals Inc. Announces FDA Approval of Two New Dosage Strengths of Suboxone® Sublingual Film (C-III) for Maintenance Treatment of Opioid Dependence

Reckitt Benckiser Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration (FDA) approval of the 4 mg and 12 mg doses of Suboxone® (buprenorphine and naloxone) sublingual film. Suboxone® sublingual film is indicated for maintenance

USFDA: List of New Drug Approval form Sept 27- October 7

October 7, 2011 Atrovent HFA(ipratropium bromide) Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Approval Cialis(tadalafil) Tablets, Eli Lilly and Co., New or Modified Indication CladribineInjection, Onco Therapies Limited, Approval Fluoxe

Regulatory Affairs & Clinical Research jobs top biotech's "must-hire" list

Regulatory Affairs Clinical Research jobs top biotech's "must-hire" list Which jobs are the most sought-after in the biotech world? Clinical development and regulatory affairs jobs, according to two biotech staffing experts: Victor Kleinman, executi

DCGI approved drug list January to November 2012

S.No Name Of Drug Indication Date of issue Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w Ointment For the prevention and treatment of surgical wound infections in adult patients undergoing surgery 03.01.12 Aceclofenac

What is NPPA and its role in Price Control of Pharma Products?

What is NPPA? National Pharmaceutical Pricing Authority (NPPA), was established on 29th August 1997 as an independent body of experts as per the decision taken by the Cabinet committee in September 1994 while reviewing Drug Policy. The Authority, in

64th Indian Pharmaceutical Congress venue has been shifted from Goa to Chennai

The 64th edition of the Indian Pharmaceutical Congress venue has been shifted from Goa to Chennai. The event will commence from December 6-9, 2012. The four-day event this year will be organized by the Association of Pharmacy Teachers of India (APTI)

PHARMEXCIL (Pharmaceuticals Export Promotion Council)

PHARMEXCIL is short form of "Pharmaceuticals Export Promotion Council" It is set up and governed by Ministry of Commerce Industry, Govt. of India About thePHARMEXCIL: The dynamic growth of Indian Pharma Industry, a knowledge based industry, and the

8 Fact of Compulsory licensing !!!

Fact 1 Compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner. It is one of the flexibilities on patent protection included in the WTO’s agreement on intellectu

Counterfeit Drugs: Definition, Factors Encouraging and Measures to Combat Counterfeiting

Definition: Counterfeit Drugs What is a counterfeit drug? In accordance with Black's law dictionary,' the term "counterfeit drug" may be used to describe а drug made by someone other than the genuine manufacturer, by copying or imitating an original

Brief introduction to career in Pharma Regulatory affairs

Introduction to Regulatory Affairs Understand the importance of regulatory affairs and what happens within the regulatory departments and authorities - and why. Regulatory Affairs (RA) is an upcoming profession within the biomedical / health produc

TOP 20 Pharmaceutical companies - The Access to Medicine Index 2012 published ranking

GlaxoSmithKline remains top of the leaguetable, but its lead is shrinking, with twonewcomers moving into the top threeclosely behind and more companies joiningthe ranks of the leaders. The industry as awhole is

New job opportunities emerging in Big Pharma

New job opportunities emerging in Big Pharma Since 2001, 300,000 pharma employees have lost their jobs, primarily in RD and sales. That's according to Clifford Mintz, the founder of BioInsights, which develops and offers bioscience education and trai

Vanderbilt University and Bristol-Myers Squibb sign collaboration agreement to develop novel treatments for parkinson's Disease

Vanderbilt University and Bristol-Myers Squibb Company (NYSE:BMY) have signed a collaboration agreement for the discovery, development and commercialization of novel therapies acting on the mGluR4 glutamate receptor, known as positive allosteric modu

National List of essential Medicine 2011 (NLEM 2011)

National List of essential Medicine 2011 (NLEM 2011) ​ National List of Essential Medicines of India 2011 (NLEM 2011)is a list of medicines, prepared by the Ministry of Health and Family Welfare, which are considered essential in India. The first suc

Current facts of Indian Pharma

Recent Facts of Indian Pharma Industry According to the IMS Health Information and Consulting Services data, Abbott's market share for the year ended May 2011 stood at 6.8%. The company's sales grew 15.1%. Its two closest competitors-Cipla and Ranbax

10 largest U.S. patent losses

In the drug business, exclusivity is everything. Once a branded drug gets generic competition, pricing power fades and sales slowly drain away, leaving drugmakers dependent on the next new thing. It's all very reasonable in theory, but when the drugs

Novartis drug Glivec receives US FDA approval for expanded use in patients with rare gastrointestinal cancer

Novartis drug Glivec receives US FDA approval for expanded use in patients with rare gastrointestinal cancer The US Food and Drug Administration (FDA) has approved an update to the Glivec (imatinib) label to recommend 36 months of treatment after su

What is meaning of Common Technical Document (CTD)?

What is CTD? TheCommon Technical Document(CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used acrossEurope,Japanand theUnited States. It was developed by theEuropean Medicines Agency(EMA,E

List of new drugs approved for marketing in India in 2012 tilldate

LIST OF APPROVED DRUG FROM 01-01-2012 to Till Date S.No Name Of Drug Indication Date of issue Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w Ointment For the prevention and treatment of surgical wound infections in adu

No. of Small Scale Pharma Companies: State Wise List in India

Sl. No State / Union Territory No. Of GMP compliant units Under process for GMP compliant Units which are not in a position to comply GMP norms No. Of units closed or licence suspended 1 JK 5 1 24 0 2 Haryana 70 71 89 0 3 Uttarnchal 28 17 1 0 4 Mah

Good Manufacturing Practices (GMP) and Its Role in Quality Control

What is Good Manufacturing Practices(GMP)? GMP (Good Manufacturing Practice) is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients, diagnostics,foods,pharmaceuti

348 medicines under National List of Essential Medicine under price control

Recent update on348 medicines under National List of Essential Medicine under price control The National Pharmaceutical Pricing Authority (NPPA) notifying revised ceiling prices for a second batch of drugs categorized under the National List of Esse
348 medicines under National List of Essential Medicine under price control
Good Manufacturing Practices (GMP) and Its Role in Quality Control
No. of Small Scale Pharma Companies: State Wise List in India
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