Alkem Labs Ankleshwar facility clears USFDA inspection

Mumbai: Through a recent BSE filing, Alkem Labs has informed that the United States Food and Drug Administration (US FDA) has conducted a GMP and Pre-Approval inspection at the Company’s API manufacturing facility located at Ankleshwar, Gujarat.

The inspection was held from 03rd April, 2023 to 07th April, 2023.

"This is to inform you that US FDA had conducted a GMP and Pre-Approval inspection at the Company’s API manufacturing facility located at Ankleshwar, Gujarat from 03rd April, 2023 to 07th April, 2023," the company further informed.

At the end of the inspection, no Form 483 was issued.

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. 

Alkem Labs is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company was founded by Samprada Singh in 1973. Alkem manufacturing operations are focused on producing generics, branded generics, over-the-counter (OTC) products, Active Pharmaceutical Ingredients (APIs), and nutraceuticals. These are available in full range of dosage forms, which include, tablets, capsules, injectables, powder for oral suspension and liquids. The company's portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O.

Alkem has an extensive manufacturing footprint which has a total of 21 manufacturing facilities, out of which 19 are in India, and 2 are in the United States. It has various manufacturing facilities at Daman, Baddi, Indore, and Sikkim. These possess regulatory approvals from agencies such as USFDA, MHRA - UK, TGA - Australia, ANVISA - Brazil, WHO - Geneva, TPD - Health Canada, PPB - Kenya, NDA - Uganda, MOH - Sudan, INVIMA - Colombia, TFDA - Tanzania, Zimbabwe, BfArM-Germany, SAHPRA-South Africa,& Other Africa, Asian & CIS Countries. They are routinely audited to ensure compliance with Current Good Manufacturing Practices (cGMP).

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