Lupin Goa facility gets 7 USFDA observations
Mumbai: Global Pharma major, Lupin, has recently announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with seven observations at its Goa facility in India.
The inspection was carried out from September 6, 2021 to September 18, 2021 and closed with seven observations.
"We are confident of addressing the observations satisfactorily and are committed to be compliant with Good Manufacturing Practice standards across all our facilities," the company stated in a BSE filing.
Read also: Lupin gets USFDA nod for partial-onset seizures drug Brivaracetam
"This may kindly be considered as a disclosure pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015," Lupin further added.
Lupin had earlier got 13 observations after the US health regulator inspection had conducted at its subsidiary's Somerset facility in New Jersey.
Read also: USFDA issues 13 observations after inspection of Lupin arm's Somerset facility
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 specializes 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.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.