Strides Pharma stock gains on USFDA nod for headache tablets

The global pharmaceutical company, Strides Pharma Science Limited, announced on Tuesday via a press filing that its fully-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore received approval from United States Food & Drug Administration (USFDA) for headache tablets. Reacting to the announcement, the share jumped almost 4 per cent on BSE.

The medication-Butalbital, Acetaminophen, and Caffeine tablets USP, 50 mg/325 mg/40 mg 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. The drug is indicated for the relief of the symptom complex of tension or muscle contraction headache. It will be marketed by Strides Pharma Inc. in the US market.

The US market for Butalbital, Acetaminophen, and Caffeine tablets USP, 50 mg/325 mg/40 mg is approximately USD 40 million, according to IQVIA MAT July 2020 data.

Strides Pharma Science has a major focus on the development and manufacture of IP-led niche finished dosage formulations. It has around 126 ANDA filings with USFDA of which, 91 ANDAs have been approved and 35 are pending approval.

At around 3.10 pm today, the share was trading down by 0.67 per cent at Rs 654.7 on BSE. It has a 52-week high of Rs 745.15 and a 52- week low of Rs 271 on BSE.