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GMP Guidelines  and News Updates


  • Jun 20, 2014

    FDA issues a warning letter to Apotex Pharmachem for data issues

    The US Food and Drug Administration has issued a warning letter to

    Hospira issues a nationwide voluntary recall of one lot of Bupivacaine HCl injection due to presence of visible particulates

    Hospira has issued a nationwide voluntary recall of one lot of

    Dr Reddys recalls nearly 13,000 bottles of anti-hypertensive drugs from US market

    Dr Reddy's Laboratories Ltd is recalling 13, 560 bottles of high blood pressure

    FDA announces a recall of Smiths Medical Portex Low Dead Space Connector

    The FDA has issued a recall of Smiths Medical Portex Low Dead Space Connector

    Functional Lapses at Wockhardt's U.S. Facility: USFDA

    Lately US Food and Drug administration has confronted about 12 methodical faults

    Pharmatech obtains authorization to export products to Canada

    Pharmatech Labs has obtained authorization from the Natural Health Products Directorate (NHPD) of

    Jun 6, 2014

    Anti-allergic drugs recalled by Zydus Cadila from US market

    Zydus Cadila issued a voluntary recall of nearly 10,200 bottles of

    FDA issues a warning letter to HeartWare International

    The US Food and Drug Administration has issued

    Alexion issues a nationwide voluntary recall of certain lots of Soliris

    Alexion Pharmaceuticals, Inc., a biopharmaceutical company has issued

    UzGerMed Pharm obtains ISO 9001 and GMP certification

    An Uzbek-German joint pharmaceutical company UzGerMed

    Fresenius Medical recalls Dialysis drug after patient death

    Fresenius Medical Care AG & Co. KGAA (FMS) has issued a voluntary recall of

    May 30, 2014

    FDA raises the concern over Wockhardt’s US unit

    The US Food and Drug Administration has raised the concern

    Parabolic Drugs obtains European GMP certification

    Parabolic Drugs announced that the company has received European

    Teva recalls around 39,000 bottles of drug from US market

    Teva Pharmaceuticals is recalling around 39,000 bottles of the

    GlaxoSmithKline recalled antidepressant drugs

    GlaxoSmithKline (GSK) Philippines Inc. has issued a voluntary

    EDOM approval to Sharon Bio-Medicine’s Taloja API plant

    Sharon Bio-Medicine Ltd has announced that the company’s active

    Eugene Oregon Inc. issues voluntary nationwide expansion of recall of dietary supplements due to presence of undeclared Pharmaceutical ingredients

    Eugene Oregon Inc. has issued a voluntary recall of

    International action against online pharmacies: FDA

    Recently, the FDA and other federal & international agencies, in partnership

    May 23, 2014

    US FDA issues a warning letter to Sun Pharmaceuticals for cGMP violations

    The US Food and Drug Administration issued a warning letter to

    Dalton Pharma Services gains compliant rating from Health Canada inspection

    Dalton Pharma Services has announced that the company has received “Compliant” rating

    WHO publishes draft on Process Validation

    WHO published a proposal for revision of appendix 7 (non-sterile process validation)

    Vivimed Labs obtains PIC/S GMP approval for its Hyderabad manufacturing facility

    Vivimed Labs has received the Pharmaceutical Inspection Convention

    Hospira issues a nationwide recall of one lot of Labetalol hydrochloride injection

    Hospira Inc. has issued a nationwide voluntary recall of

    MediWound announces successful GMP audit by the Israeli Ministry of Health

    MediWound Ltd. announces the successful completion of a

    May 16, 2014

    Sun Pharma recalls 400,000 bottles of drugs from US

    Sun Pharmaceuticals has issued a recall of about 400,000 bottles of anti-depressant and

    Anti-hypertensive drugs recalled by Wockhardt from US market

    Wockhardt Limited is voluntarily recalling 109,744 bottles of

    Hospira issues nationwide recall of Dobutamine Injection due to presence of visible particulates

    Hospira Inc. has issued a voluntary nationwide recall of one lot

    Three batches of Transplant medicine recalled from PHL market

    A pharmaceutical company has recalled three batches of thymoglobuline

    May 9, 2014

    Nationwide recall of common anaesthesia drug after patients fall ill

    The Therapeutic Goods Administration (TGA) has issued a nationwide recall of

    Anti-allergy drug recalled by Ranbaxy from US market

    Ranbaxy Laboratories Ltd. is voluntarily recalling nearly 30,000 blister packs of

    Sun Pharma shuts down Detroit manufacturing plant

    Sun Pharma has decided to close its manufacturing plant at Detroit, US owned by

    EMA publishes a draft Guideline on Process Validation of Biotechnology-Derived products

    The EMA has published the draft entitled as “Guideline on process validation

    MTI’s China facility gains GMP certification

    Metabolic Technologies Inc. (MTI) announced that it has

    Indian Drug makers face problems in US due to Documentation

    The problems faced by Indian drug makers are in the US are not

    May 2, 2014

    Allergy Therapeutics gains MHRA Good Manufacturing Practices certification

    Allergy Therapeutics announced that the Medicines and Healthcare Products

    Strides Arcolab obtains USFDA approval for India facility

    Strides Arcolab has announced that its oral dosage form

    Labeling changes for extended release, long acting Opioids approved by FDA

    Recently, FDA has approved the class wide labeling changes for

    Nano Well-being Health issues voluntary recall of Super Arthgold due to undeclared drug ingredients

    Nano Well-being Health has issued voluntary nationwide recall of two

    April 25, 2014

    Lupin recalls Antibiotic and Antibacterial drugs from US market

    Lupin issued a voluntary recall of 9,210 bottles of its antibiotic drug Suprax, used

    Another US FDA import alert to Indian API plant: Canton Laboratories

    The US FDA has issued an import alert of drug products made at

    FDA warns consumers for risks to Cortisone injections in the spine

    The Food and Drug Administration is warning consumers that

    Glenmark issues a voluntary recall of ulcer drug in US

    Glenmark Pharmaceuticals has issued a voluntary recall of

    EMA publishes new Guideline on Stability Testing for Applications for Variations

    European Medical Agency (EMA) has published a new Guideline

    GlaxoSmithKline recalls Crocin and Calpol after state FDA order

    GlaxoSmithKline has issued a nationwide recall of its extensively sold paracetamol brands like Crocin

    April 18, 2014

    WHO revised Appendix 7 for Non-sterile Process Validation

    The World Health Organization (WHO) has published a proposal for

    United States Pharmacopoeia (USP) revised General chapters on Good Distribution Practices (GDP)

    USP has revised General Chapters on Good Distribution Practices (GDP). The revision

    FDA warns customers for the use of Zi Xiu Tang Bee Pollen

    The US Food and Drug Administration (FDA) is warning customers to

    WHO announces Swiss Pharma Nigeria GMP compliant

    The World Health Organization (WHO) has declared Swiss Pharma Nigeria

    Lonza obtains HSA GMP certification for its Singapore facility

    Lonza Bioscience Singapore Pte Ltd announced that it has received

    April 11, 2014

    FDA publishes new Guidance on Post-Approval Changes

    The US Food and Drug Administration (FDA) has published a

    EU publishes final version of Chapter 6 Quality Control

    European Commission has published the final version of Chapter 6 Quality

    Ranbaxy’s two plants remain debarred from export to EU

    Export of medicine manufactured at Ranbaxy’s Toansa and Dewas

    GH Chemicals Ltd. receives World’s first Zinc oxide GMP license

    GH Chemicals Ltd. is a world class manufacturer and exporter of

    Anuh Pharma gains GMP certificate for three Erythromycin products

    Anuh Pharma is a part of SK groups that has been serving the

    Novel obtains NSF Dietary Ingredient GMP Facility Registration

    Novel Ingredient Services has announced that the company has been

    April 4, 2014

    US FDA issues warning letter to GlaxoSmithKline

    US FDA has issued a warning letter to GlaxoSmithKline for alleged

    US FDA issues import alert to Apotex’s Indian drug plant

    The Food and Drug Administration (FDA) has issued an import alert to Apotex’s Bangalore site

    Kopran Ltd receives UK MHRA Good Manufacturing Practices certification

    Kopran Ltd announced that the the UK, Medicines andHealthcare products

    GMP certification for 11 BASF sites for cosmetic ingredients

    BASF, world’s leading chemical company, has been awarded the Good

    Alli® weight loss products recalled by GlaxoSmithKline from US and Puerto Rico markets

    GlaxoSmithKline (GSK) is voluntarily recalling all Alli® weight loss products from

    Anlit obtains Therapeutic Goods Administration GMP certification

    Anlit announced that it has received GMP (good manufacturing practices) certification

    Nova products recalls 7 brands of dietary supplements due to undeclared Pharmaceutical ingredient

    Nova products issued a nationwide voluntary recall of 7 brands of

    March 28, 2014

    FDA decreases domestic GMP inspections

    The FDA plans to decrease its routine quality or GMP inspections

    US FDA issues warning letter to Smruthi Organics Limited for data issues

    The US FDA issued a warning letter to Smruthi Organics Limited for deviations

    Cristalia obtains ANVISA approval for production of biosimilar drugs

    Cristalia has announced its ANVISA approval for the production of biosimilar

    Pure Edge Nutrition recalls Bella Vi brand products due to undeclared Sibutramine and Phenolphthalein

    Pure Edge Nutrition issued a nationwide voluntary recall of Bella Vi

    March 21, 2014

    EMA revised Process Validation Guideline

    EMA has revised its process validation guideline after the publication of the

    FDA warns Akrimax Pharmaceuticals for improper Facebook marketing

    FDA issued a warning to Akrimax Pharmaceuticals for improper advertising of

    Dr. Reddy recalls heartburn drug from US market

    Dr. Reddy has issued a voluntary recall of Lansoprazole delayed

    Shire Pharmaceutical issues nationwide voluntary recall of 3 lots of VPRIV (Velaglucerase Alfa for Injection)

    Shire Pharmaceuticals has announced the nationwide voluntary recall of o

    FDA Import alert for two Chinese companies

    The European Union and US FDA have significantly increased

    China Biologic receives GMP Certification for its Guizhou Taibang Facility

    China Biologic Products is a fully integrated plasma-based biopharmaceutical

    US doctors concerned on Indian drug quality, after outbreak of FDA recalls

    Some U.S. doctors are getting concerned about the quality of generic

    March 14, 2014

    US FDA imposes ban on products made at Sun Pharmas Gujarat plant

    The US Food and Drug Administration (FDA) has issued an import alert on generic drug

    US FDA issues a warning letter to Canton Laboratories

    The US FDA issued a warning letter to Canton Laboratories for cGMP violations

    Ranbaxy recalls Generic Lipitor in US due to dose mix-up

    Ranbaxy Laboratories has recalled over 64,000 bottles of the generic version

    FDA: Draft Guidance to Validation of Analytical Methods

    The FDA has published Draft guidance for Industry entitled Analytical Procedures

    Pfizer issues nationwide recall of 3 lots of Venlafaxine (Effexor) due to possible contamination

    Pfizer has issued a voluntary nationwide recall of 3 different lots of the antidepressant

    US warned Indian suppliers for drug makers on plant practices

    US regulators warned Indian companies that supplies ingredients for major

    March 7, 2014

    Jubilant Life gets US FDA approval for Canada Plant

    Jubilant Life Sciences has 10 manufacturing facilities in India, US and Canada and is s

    New GMP certification to commence from April in Taiwan

    The Industrial Development Bureau (IDB) under the Ministry of Economic Affairs (MOEA) has rolled out a

    Chinas Drug watchdog cancels 68 Business Licenses

    Chinas food and drug safety watchdog has revoked 68 drug businesses licenses in

    Nepals pharmaceutical companies rising on the grounds of quality

    The entry of private sector pharmaceutical industries after 1990s changed the

    February 28, 2014

    US FDA issues warning letter to USV Limited for data integrity

    The US FDA issued a warning letter to USV limited for failing to ensure the data integrity

    FDA starts Secure Supply Chain Pilot Program to raise the security of imported drugs

    US Food and Drug Administration have announced the initiation of Secure Supply Chain

    CFDA revised Medical Device Regulations

    The China Food and Drug Administration (CFDA) have adopted the draft amendment

    Rockwell Medical gains Japanese Patent Issuance for Triferic GMP Formulation

    Rockwell Medical is a fully-integrated biopharmaceutical company targeting

    Private Label Nutraceuticals obtains GMP Certification

    Private label Nutraceuticals obtains GMP certification through ASI Food and Safety Consultants

    February 21, 2014

    FDA brings up the Safety and GMP Issues for Indian Drugs and increasing drug inspectors in India

    An alert has been raised by US FDA over the drugs manufactured

    Selvita Group obtains a GMP Compliance Certificate

    Selvita Group, with a goal to develop solutions that contribute to the

    Ben Venue Laboratories issues voluntary Recalls for Acetylcysteine Solution 10 Percent

    The FDA announces that Ben Venue Laboratories Inc. of Bedford

    Indian Pharma companies should follow GMP regulations strictly: USFDA

    US-based online compliance and regulatory learning solutions

    Agreement with Republic of Korea in the field of therapeutic products: Swissmedic

    During the state visit of President of the Republic of Korea, a Memorandum of Understanding

    IDMA forms alliance with UL to increase the compliance level in pharma companies

    Indian Drug Manufacturers Association (IDMA) ties up with

    February 14, 2014

    Revised GMP principles by EU on Qualification and Validation

    Good manufacturing practices guidelines are of significant importance

    Indoco Remedies gains GMP Compliance Certificate for Goa plant

    Indoco Remedies is a Pharmaceutical company engaged in manufacturing and

    FDA: Guidance Agenda 2014

    The FDA has released its yearly guidance agenda which includes

    Refusal of US FDA for export from Ranbaxys banned units

    The head of US FDA has refused the petition of Ranbaxy Laboratories

    February 7, 2014

    Venus Remedies bags GMP certification from Indonesia for Baddi unit

    Venus Remedies announced that it has received an Indonesian

    Medical fraternity awaits clarification on quality of Ranbaxys products

    After repeated regulatory action against manufacturing facilities

    International collaboration enhanced with increased GMP inspections

    With the increasing need for improved global regulatory control

    GMP Guide for Healthcare establishments

    Good manufacturing practice (GMP) standards are important

    Daiichi concerned about Ranbaxys manufacturing issues

    Last week, the USFDA banned Ranbaxys Toansa plant from importing

    Ranbaxy doubts staff involvement behind issues at Toansa plant

    After the US Food and Drug Administration (USFDA) raised concerns

    January 31, 2014

    Ranbaxys Toansa plant products banned by USFDA due to data integrity issues

    Ranbaxy Laboratories had entered into a $500-million settlement in May

    FDA notes flies in sample storage room at Toansa plant

    Not limiting the issues at Toansa plant to only data integrity, USFDA also

    EU, UK and Aussie regulators focus on Ranbaxys Toansa plant

    After USFDA, even the other drug regulators are being more vigilant

    Indian drug regulator too watches for Ranbaxys Toansa plant

    With a host of activities occurring around Ranbaxys Toansa plant

    USFDA issues warning letters for GMP violations

    There has been a general increase in warning letters

    Quinapril tablets recalled by Lupin Pharmaceuticals from the US market

    After failing the impurity specification test for multiple lots of quinapril tablets,

    January 24, 2014

    Indian drug regulator considers changes in labeling norms

    Recently there were concerns that consumers can get confused

    USFDA releases guidance on Dear Doctor letters

    The US Food and Drug Administration (FDA) has presented

    Series of warning letters for a medical food manufacturer

    Fourth warning letter in the last 9 months has been issued to NVN Therapeutics

    Summary of technical reports accepted by TGA

    Australian companies have been facing difficulties in obtaining

    Sterile pharmaceutical products get revised GMP by SFDA

    China Food and Drug Administration (SFDA) has announced

    January 17, 2014

    More concerns over Ranbaxys Indian manufacturing facilities and Toansa plant

    In a recent development, the US health regulator, USFDA, has raised concerns over

    Warning letter to dietary supplement company for improper use of search terms

    The Federal Food, Drug and Cosmetic Act (FD&C Act) regulates the use of specific marketing

    Philips healthcare criticized by FDA for not reporting device recall

    The USFDA has sent a warning letter to Philips Healthcare, which is a device

    Schedule M soon to be at par with WHO-GMP certification

    Indian government plans to consider Schedule M to be at par with the WHO-GMP

    EMA publishes GMP non-compliance data

    European Medicines Agency (EMA) has published the details of the manufacturers

    January 10, 2014

    FDA warns a Canadian device manufacturing company

    DNA Genotek, a Canadian diagnostics manufacturer recently received a warning

    FDA releases draft guidance for blood glucose monitoring device manufacturing

    The USFDA, has released two extensive draft guidance that would help

    New Photosafety guideline to be implemented by EU, US and Japan

    The photosafety guideline, which is also known as S10, is aimed at harmonizing

    Health Canada gives a nod for Ranbaxys anti-dementia drug

    The drug company, Ranbaxy, which has been under scanners of global

    Diabetes drug with a novel approach approved by USFDA

    The U.S. Food and Drug Administration approved Farxiga

    January 3, 2014

    Expert panel appointed for confirming drug safety

    While there are a number of drug combinations applications pending to be cleared, an expert panel is considered

    FDA heads towards implementing compounding provisions of Drug Quality and Security Act

    FDA is moving towards implementing the compounding provisions of the

    No permit for top vaccines in China

    Chinas leading three hepatitis B vaccine producers have failed to obtain

    Banning PET container packing for medicines opposed by PCMA

    Union Health Ministrys Drug Technical Advisory Board (DTAB) has recommended

    Elder pharma to try new therapeutic areas

    Elder Pharmaceuticals Ltd (EPL), a drug firm plans to expand its

    December 27, 2013

    Another US import alert for Wockhardts vet drugs

    Wockhardt has been in focus for the past few months and supposedly been troubled by bans and import alerts by some of the

    Heart device approved by NICE

    The National Institute for Health and Care Excellence (NICE) of UK, recommends the use of

    Daiichi considers Japanese experts to help Ranbaxy meet FDA norms

    After a recent development, it is believed that Daiichi Sankyo, which is the parent

    Sun Pharma units product in present form disapproved by FDA

    According to the announcement made by Sun Pharma Advanced Research

    December 20, 2013

    Warning letter from FDA to cancer doctor in Houston

    Stanislaw Burzynski, a doctor in Houston has received a harsh warning letter

    Anti-bacterial soaps hit by FDA

    According to the statement made by FDA there is no evidence that supports

    First device for migraines gets FDA approval

    FDA has announced that it has approved the first medical device that

    FDAs warning letter refers Hemp-laced beverage as a drug

    FDA has issued a warning letter, which is rare in its nature, to Green Planet Inc

    Draft guidance for antibiotics focuses on superiority

    This is the backdrop of the draft guidance released in July 2013, which

    December 13, 2013

    EU legislation gives good manufacturing practice guidelines for food contact materials

    All the exporters of food products or working with all materials and substances that

    Import of ROK medical products banned in China

    A pharmaceutical company, Daewoong Pharmaceutical Co. Ltd, from Republic of Korea (ROK)

    DNA testing company positive about their business even after FDA warning

    Last month, 23 and Me, a DNA testing company received a warning letter from the USFDA

    Proposed marketing agreement for green leafy vegetables terminated by USDA

    A marketing agreement to provide regulation for handling of fresh leafy green vegetables

    Echinaforce announced as one of top supplements for cold and flu – New York inspection

    A.Vogel produces supplement for cold and flu named Echinaforce, which is ranked as one of the top three supplements

    December 6, 2013

    USFDA issues warning letter to Jubilant Lifesciences Ltd

    Jubilant Lifesciences Ltd announced that it has received a warning letter from

    Wockhardt advised to hire consultant for data check

    Recently, concerns were raised over manufacturing facility of the Mumbai-based

    Indias drug manufacturing facilities to be showcased to global regulators

    India plans to arrange for a programme that would help in showcasing Indias

    GEs FlexFactory (TM) biomanufacturing platform selected by JHL Biotech for Taiwan facility

    JHL Biotech has selected GE Healthcares FlexFactory (TM) biomanufacturing platform

    Osmanias manufacturing facility receives FDA pre-approval inspection

    Oasmia Pharmaceutical AB, a Swedish pharmaceutical company, announces

    Inclusion of Good Pharmacy Practice in CDA bill to be considered – India

    The Parliamentary Standing Committee on Health and Family Welfare examines

    November 29, 2013

    USFDA presses import restrictions on Wockhardts Chikalthana plant

    The USFDA has imposed import restrictions on Chikalthan manufacturing

    Pharmaceutical companies need to be careful of the FDA import alert pattern

    Recently many Indian pharmaceutical companies have been

    USANA confirms that labels match products

    USANA health sciences, which a global company dealing with nutrition products

    Mithra Pharma working to make way for Indian companies in EU market

    Mithra Pharma, which is a Belgium based drug Company, has plans to

    November 22, 2013

    Astella receives FDA warning for its stress test drug

    According to new warning issued by the US Food and Drug Administration

    Biocad obtains GMP certification in Ukraine

    Biocad is a biopharmaceutical company, is a leader in Russian

    Youngevity International has announced the acquisition of Biometics

    Youngevity International has its subsidiary, Youngevity Essential Life Sciences

    API production of Merck at Puerto Rico ended

    Pharmaceutical company, Merck has announced that the company

    Council of Agriculture to change CAS within a month

    The Council of Agriculture announced that there would possibly be

    November 15, 2013

    DCGI halts Sun Pharmas clinical research in Mumbai laboratory

    Indian health regulator, the Drug Controller General of India, has asked

    Hospira gets another Form 483

    Hospira has now been caught in trouble due its manufacturing plant in

    Ranbaxys USFDA nod obtained by fraudulent data brought to notice

    It has been noticed that Ranbaxy, had taken the aid of fraudulent data

    DCGI lines up GuruFcure for making up data to obtain manufacturing approvals

    Indian drug regulator, DCGI, has spotted, GuruFcure a contract drug

    New draft guidance for hearing aids manufacturers released by US medical device regulators

    New draft guidance has been released by the US medical device regulators, which

    Repligen expands its US manufacturing facility

    Repligen, which is a US based life sciences firm in

    GMP certification to be reviewed by Taiwan Ministry

    It has been announced that the Ministry

    Wockhardt experiences a revenue hit after MHRA concerns on Nani Daman facility

    The Mumbai based pharma major Wockhardt announced

    Pfenex obtains malaria production process sub contract

    San Diego-based Pfenex Inc., which is a biotechnology company, declared


    November 1, 2013

    Sun Pharmecutical addresses USFDAs concerns

    During this year, the United States Food and Drug Administration conducted

    Lupin to produce additional strengths of cholesterol drug

    Mumbai-based drug company Lupin announced the approval of additional

    New safety standards for animal food makers

    Recently, the USFDA has proposed a rule to formulate current

    Animal food manufacturing facilities need to register under FD&C Act and develop hazard analysis

    With the background of proposed regulations for preparing

    Ban on Heels medications import to Ukraine lifted

    Import of medicinal products manufactured by Heel medications

    USFDA approves Unichems generic hypertension tablets

    Unichem Laboratories announced the receipt of approval for

    October 25, 2013

    Regulatory concerns make Wockhardt recall 5 drugs

    Wockhardt, has been facing regulatory issues all throughout this year. The latest

    Indian herbal drug firms should follow good manufacturing practices

    Indian herbal industry is gaining popularity and has the potential to stand

    Smruthi Organics faces USFDA heat for GMP issues

    Recently many Indian drug companies have been under USFDA scanner, especially

    AHPAs plea to FDA to include regulations on Form 483

    The American Herbal Products Associations petition aims at making

    Tough food inspection to be conducted in Taiwan

    According to Ma Ying-jeou, there is a need for tougher food inspections to

    Another Wockhardts manufacturing plant caught under MHRAs vigilance

    Wockhardt, a Mumbai based pharmaceutical major, had recently received


    October 18, 2013

    UK health regulator withdraws Wockhardt unit certification

    UKs health regulator, Medicines and Healthcare Products Regulatory Agency (MHRA)

    Ranbaxys U.S. plant gets USFDA clearance

    According to the US Food and Drug Administration (FDA), their findings about the

    MedPharm opens new GMP facility in Guilford, UK

    MedPharm, a reputed pharmaceutical company has opened a new good manufacturing

    New guidance for US medical device manufacturers

    A new updated guidance document for the submission of electronic copies

    Neuland labs gets Leadership award for cGMP excellence

    Neuland Laboratories Ltd is a pharmaceutical manufacturing company

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