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USFDA completes Pre-Approval inspection at Granules India’s Hyderabad facility

16 Jan 2023 Evaluate

United States Food and Drug Administration (USFDA) has completed Pre-Approval inspection (PAI) at Granules India’s Gagillapur facility located at Hyderabad, Telangana, from January 09, 2023 to January 13, 2023 with 3 observations and the Company will respond to these observations within the stipulated time period.

Gagillapur facility manufactures Finished Dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs).

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

Peers
Company Name CMP
Sun Pharma. Inds. 1752.50
Dr. Reddys Labs. 1180.00
Cipla 1305.00
Lupin 1942.00
Zydus Lifesciences 1115.20
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