Natco Pharma: USFDA raises flags post inspection

United States Food Administration (USFDA) conducted an inspection at Natco Pharma’s facility located in Mekaguda Village near Hyderabad. Post completion of the inspection, USFDA issued six observations.

The inspection took place from August 5 to 9, 2019, at the Active Pharmaceutical Ingredient (API) facility of Natco Pharma located near Hyderabad. In a press release, the company reported that the six observations are mostly procedural in nature. The observations mentioned in Form 483 are related to supplier and service agreements which must be made more robust in nature, procedural improvements needed in the gowning section and also for revalidation protocols and for the approval of alternate supplier sources, more effective training required for the employees working in manufacturing and packaging areas, diagnosis of visual stains observed in early-stage reactors, raising incident reports, etc. According to the press release made by Natco Pharma, these observations are not related to data integrity and thus the company should be able to provide justifications and corrective action plan in the coming 15 working days.

Natco Pharma Limited is one of the fastest-growing pharmaceutical companies in India.  The company develops, manufactures and markets finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs).

On Friday, the stock of the company closed at Rs. 551.85 per share, down by 0.14 per cent or Rs. 0.80 per share. The 52-week high is Rs. 849 and 52-week low is Rs. 482 on BSE. The shares of Natco Pharma would be in focus on Tuesday as the markets were closed on Monday on accounts of Eid-al-adha.