United States Food and Drug Administration (USFDA) has concluded Pre-Approval Inspection (PAI) for Seven Products and Good Manufacturing Practice (GMP) Inspection at the Gland Pharma’s Pashamylaram facility at Hyderabad between June 15, 2023 and June 27, 2023.
The inspection was concluded with (1) 483 observation. This observation is procedural in nature and the corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period. The observation issued is neither a repeated observation nor related to data integrity.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1486.55 |
Dr. Reddys Lab | 5860.25 |
Cipla | 1482.55 |
Zydus Lifesciences | 1072.35 |
Lupin | 1613.65 |
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