Last Updated on October 15, 2024 by The Health Master
Mumbai: Drugmaker, Lupin, has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with four observations at the company’s Tarapur manufacturing facility.
The inspection was carried out between March 22, 2022 and April 4, 2022.
“We are confident of addressing the observations to the U.S. FDA’s satisfaction. We are committed to adherence and full compliance with CGMP regulations and uphold the highest quality standards across our manufacturing sites,” the company said in a BSE filing.
Lupin had earlier received 13 observations from the USFDA after an inspection at its US-based wholly-owned subsidiary Novel Laboratories, Inc.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle East regions.
The company spacializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas.
Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue on research and development in FY21.Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
USFDA gives 13 observations to Lupin
USFDA complete audit of Granules Pharmaceuticals with 3 observations
USFDA issues 3 observations on Zydus manufacturing unit
USFDA issues 3 observations to Granules Pharmaceuticals Inc
USFDA completes audit at MSN Pharma with zero observations
USFDA issues 6 observations to Biocon’s Malaysian facility
Certain Products recalled due to Microbial Contamination
USFDA approves Cell Therapy for earlier lymphoma
Drug Recall: IDArubicin Hydrochloride Injection recalled due to this reason
USFDA gives 13 observations to Lupin
Govt further extends timeline to apply for slots under PLI scheme
CDSCO panel gives nod to Roche for Anticancer Drug Entrectinib Capsules
Nutraceuticals Regulations 2022 to encourage Pharma Industry
Telangana to fill posts of 18 Drug Inspectors, 442 Pharmacists and 15 junior Analysts
NPPA updated price lists: Download
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: