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The inspection was concluded with zero 483 observations and no discussion items. This inspection has now been closed with the issuance of the establishment inspection report (EIR). The facility is classified as ‘No Action Indicated’ (NAI).
This unit of Shilpa Medicare is engaged in testing biological samples of clinical studies and BA/BE studies in human subjects as per global regulatory requirements. This is a newly set up centre for bio-analytical testing and this is the first regulatory inspection and approval for this site from USFDA. This facility is approved by EMA, Europe.
Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.
The company reported a consolidated net profit of Rs 24.50 crore in Q4 FY24 as against a net loss of Rs 8.04 crore posted in Q4 FY23. Revenue grew by 10.7% year on year to Rs 219.69 crore during the quarter.
The scrip declined 1.56% to currently trade at Rs 586.55 on the BSE.
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