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  • Glenmark Pharma gets 5...

Glenmark Pharma gets 5 USFDA observations for Goa facility

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-05-23T16:47:03+05:30  |  Updated On 23 May 2022 11:17 AM GMT
Glenmark Pharma gets 5 USFDA observations for Goa facility

Mumbai: Drugmaker, Glenmark Pharma, has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with five observations after an inspection at the Company's formulation manufacturing facility based out of Goa, India.The inspection was conducted between May 12, 2022 and May 20, 2022."This is to inform you that the U.S. FDA has issued Form 483 with five...

Mumbai: Drugmaker, Glenmark Pharma, has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with five observations after an inspection at the Company's formulation manufacturing facility based out of Goa, India.

The inspection was conducted between May 12, 2022 and May 20, 2022.

"This is to inform you that the U.S. FDA has issued Form 483 with five observations after an inspection at the Company's formulation manufacturing facility based out of Goa, India between May 12, 2022 and May 20, 2022," the company stated in a BSE filing.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

"The company is committed to undertake all necessary steps required to address their observations at the earliest. The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe," Glenmark added.
Read also: Glenmark Pharma bags USFDA nod for prostate cancer drug Abiraterone Acetate

Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.

Read also: Glenmark gets CDSCO panel nod to manufacture and market COPD drug

glenmark pharma glenmark glenmark news USFDA goa facility USFDA inspection 
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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