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About 814 results for "Fda Good Manufacturing Practices"

New american norms force Wockhardt to withdraw over 50 lakh bottles of drugs
Business Insider India

New american norms force Wockhardt to withdraw over 50 lakh bo...

Deviations in current good manufacturing practice norms laid down by the American health regulator has prompted Wockhardt to recall over 50 lakh bottles of various drugs, used for treating ailments like high blood pressure and ulcer, in the US ... Business Insider India, 4 weeks ago
FDA Finds Deviations in Bio-Rad's cGMP Practices BioPharm International, 1 month ago
Wockhardt dips after the US FDA asks to recall drugs Business Standard, 2 months ago

11 images for Fda Good Manufacturing Practices

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FDA hits Mylan's Indian plants with warning letter

The FDA has warned Mylan about its failure to comply with good manufacturing practice guidelines The FDA has served Mylan with a warning letter citing contamination at three of its manufacturing facilities in India. Inspections carried out by ...
 Pharmafile1 week ago India's biopharma woes grow with FDA Emcure plant ban  Fierce CRO1 month ago The ABCs of GMP Compliance  Natural Products Industry Insider1 month ago FDA bans drug imports from Indian plant  Pharmafile1 month ago
Natural Products Industry Insider

Scientifically Sound Specifications: No "By-Inputs" Here

The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, require that each batch of a finished dietary supplement product must be ...
 Natural Products Industry Insider4 days ago Elements of Current Good Manufacturing Practices (cGMP) for Complying with the Food Safety Modernization Act (FSMA): 2-Day In-Person Seminar (Orlando, FL)  Research and Markets1 month ago

Food safety and recalls a global challenge: manufacturers can reap long-term benefits from short-term compliance adjustments

MCC interviews Smitha G. Stansbury, a partner in the FDA and Life Sciences practice group of King & Spalding, resident in the firm's Washington, D.C. office. Ms. Stansbury focuses her practice in the areas of FDA-regulated food safety and food ...
 Lexology4 weeks ago
Sys-Con Media

Pace Wellness Enters Into Acquisition Agreement For Breakthrough Oral Thin-Film Technology

Pace has everything in place to develop new products from its regulatory-compliant FDA and cGMP (Current Good Manufacturing Practices) manufacturing facility in California The OTF drug delivery platform technology opens up boundless opportunities ...
 Pettinga Financial Advisors1 month ago Pace Wellness to Buy Oral Thin-Film Technology from Manufacturing Partners  Bloomberg1 month ago

FDA trains local manufacturers on Process Validation

Accra, Aug 27, GNA - The Food and Drugs Authority (FDA) is training local manufacturers of pharmaceutical products on process validation for non-sterile finished pharmaceutical products to help them meet the current codes of Good Manufacturing ...
 NigerianHerald.com4 days ago US Regulator Denies Approval for SPARC's Anti-Glaucoma Eyedrop  NDTV Profit1 month ago FDA recalls products, suspends operations of 2 pharma firms  Manila Bulletin1 month ago Meds from 3 drug firms recalled  Philippine Daily Inquirer1 month ago

FDA Quality Metrics Offer Regulatory Carrots for Manufacturers

Biopharmaceutical companies able to produce high quality drugs and biologics on a regular basis may merit less frequent plant inspections and reduced reporting of post-approval manufacturing changes, based on a set of quality metrics indicating ...
 PharmTech.com1 month ago
Digital Journal

Compounded drugs in syringes warning

According to the U.S. Food and Drug Administration (FDA), compounded or repackaged drugs stored in 3 milliliter (ml) and 5ml syringes manufactured by Becton-Dickinson (BD) should be avoided unless there is no there suitable alternative. The reason ...
 Digital Journal1 week ago The compounding regulations surrounding drug compounding  Lexology1 month ago

Two ends of the pharma spectrum

In the last few years, Indian pharma companies seem to have not bothered with basic things, such as manufacturing practices. Photo: Pradeep Gaur/Mint There were two pieces of news in the same sector that caught the eye this week. One told the ...
 Livemint.com1 month ago Lupin's Goa unit comes under USFDA scanner  Economic Times1 month ago Indian Pharmaceutical Company Faces Heat From Health Regulatory Authorities In The US  MedIndia1 month ago Aurobindo Pharma comes under USFDA lens, again  Economic Times1 month ago

Wearable gizmos vs. medical devices: how companies can comply with FDA security recommendations

Kaye Scholer Counsel Helen Christakos, whose practice areas include intellectual property, technology and data security, discusses the U.S. Food and Drug Administration's recent decision not to closely regulate so-called general wellness products ...
 Lexology1 month ago
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