Strides Pharma’s arm gets USFDA nod for Butalbital, Acetaminophen, Caffeine Tablets

22 Sep 2020 Evaluate

Strides Pharma Science’s step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg, of Actavis Laboratories FL, Inc.

According to IQVIA MAT July 2020 data, the US market for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg is approximately $ 40 Mn. The product will be marketed by Strides Pharma Inc. in the US market.

The company has 126 cumulative ANDA filings with USFDA of which 91 ANDAs have been approved and 35 are pending approval.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

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