Industry

USFDA issues 6 observations to Glenmark Baddi Facility

The company said that it is committed to undertake all necessary steps required to address their observations at the earliest.

The Health Master

June 24, 2022

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Last Updated on October 15, 2024 by The Health Master

The drug maker Glenmark Pharmaceuticals announced that the US drug regulator has issued Form 483 with six observations to the company’s formulation manufacturing facility in Baddi, Himachal Pradesh (India).

The U.S. Food and Drug Administration (USFDA) has issued Form 483 with six observations after an inspection at Glenmark Pharmaceuticals’ formulation manufacturing facility based out of Baddi in Himachal Pradesh (India) between 13 June 2022 and 22 June 2022.

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The facility caters to the production of oral solids and liquid orals, external preparations like lotions, creams and respiratory segment products.

The company said that it is committed to undertake all necessary steps required to address their observations at the earliest.

“The company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe,” it added.

Glenmark Pharmaceuticals is a global pharmaceutical company with a presence across specialty, generics, and OTC businesses.

Other observations issued by USFDA to firms

USFDA issues 8 Observations to Panacea Biotec for Baddi Facility

USFDA gives 5 observations to Glenmark Pharma for Goa facility

USFDA gives 10 observations to Sun Pharm

USFDA gives Zero Observations to SMS Lifesciences

USFDA issues 4 Observations to Lupin for Tarapur Facility

USFDA gives 13 observations to Lupin

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