Glenmark gets one USFDA observation for Aurangabad facility
New Delhi: Glenmark Pharmaceuticals Limited has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with one observation after an inspection at the Company's formulation manufacturing facility based out of Aurangabad, India.An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions...
New Delhi: Glenmark Pharmaceuticals Limited has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with one observation after an inspection at the Company's formulation manufacturing facility based out of Aurangabad, India.
The inspection was held between June 27, 2022 and July 1, 2022.
"The company is committed to undertake all necessary steps required to address their observation at the earliest. The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe," the company said in a BSE filing.
Read also: Glenmark receives 6 USFDA observations for Baddi facility
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.
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