Strides Pharma Science’s step?down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg from the United States Food & Drug Administration (USFDA). The product is a generic version of Fioricet with Codeine Capsules, 50 mg/325 mg/40 mg/30 mg, of Teva Branded Pharmaceutical Product R&D, Inc.
The US market for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg is approximately $10 million. The product will be marketed by Strides Pharma Inc. in the US market. The company has 124 cumulative ANDA filings with USFDA of which 87 ANDAs have been approved and 37 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.
