Strides Pharma gets EIR for Bengaluru facility from USFDA

Strides Pharma Science Limited has informed the bourses that its flagship facility (KRS Gardens) in Bengaluru has received an establishment inspection report (EIR) thereby, confirming the successful closure of the inspections.

The inspections were done by United States Food & Drug Administration (USFDA) in March 2020.

Earlier this month, the company’s step-down wholly-owned subsidiary, Strides Pharma Global Pte Limited (Singapore) has received an approval for Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg from USFDA. The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals Inc (previously Heritage Pharmaceuticals Inc).

The company has 123 cumulative ANDA filings with USFDA of which 84 ANDAs have been approved and 39 are still pending approval.

Strides Pharma operates in the regulated markets and has an ‘in Africa for Africa’ strategy along with an institutional business to service donor-funded markets. The company’s global manufacturing sites are located in India-Bengaluru (two locations), Pondicherry and Chennai, Singapore, Milan (Italy), Nairobi (Kenya) and Florida (United States).

On Thursday, the stock of Strides Pharma opened at gap-up of 5.7 per cent at Rs 338 from its previous close of Rs 319.65 on BSE. In the early morning trading session, it surged to Rs 346.40.