Shilpa Medicare slips after Analytical Service Division gets four observations

2 May 2022 , 12:36 PM

The facility underwent a United States Food and Drug Administration (USFDA) inspection from 26 April 2022 to 29 April 2022. The inspection was launched after the company submitted four abbreviated new drug applications (ANDAs) seeking approval to use Nacharam site as alternate testing laboratory.

The drug company said that the inspection was closed with four observations, which are related to improvements in existing procedures and are addressable. The company assured that it will be submitting responses within stipulated timeline and will be implementing corrective actions to address the observations.

The Analytical Services Division started analytical testing operations from May 2021. Shilpa Medicare said it is the first USFDA inspection of the facility. The facility has not been used till now to test products for commercial dispatch into US/EU markets.

Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.

On consolidated basis, the pharma company reported 24.8% rise in net profit to Rs 9.57 crore on 42.4% increase in net sales to Rs 272.30 crore in Q3 FY22 over Q3 FY21.

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