Strides Pharma Science Limited (Strides) has made a notable advancement in the field of mental health treatment by securing approval from the United States Food & Drug Administration (USFDA) for its Fluoxetine Tablets 10 mg and 20 mg. This development is significant for Strides’ subsidiary, Strides Pharma Global Pte. Limited, Singapore, positioning the company as […]
Strides Pharma Science Limited (Strides) has achieved a significant milestone in the pharmaceutical industry with the United States Food & Drug Administration (USFDA) approval of Pregabalin capsules, spanning dosages from 25 mg to 300 mg. This approval was granted to Strides Pharma Global Pte. Limited, Singapore, a step-down wholly owned subsidiary of Strides, marking a […]
Strides Pharma Science Limited (“Strides”) has joined forces with Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) to introduce Icosapent ethyl acid soft gel capsules to the market. This new product, referencing VASCEPA®, is set to be commercialized by Amneal starting in the fourth quarter of 2023. The in-licensing of this product from Strides, a global pharmaceutical […]
Strides Pharma Science Limited, through its subsidiary Strides Pharma Global Pte. Limited, Singapore, has recently achieved a significant milestone by receiving approval from the United States Food & Drug Administration (USFDA) for its Sodium Sulphate, Potassium Sulphate, and Magnesium Sulphate Oral Solution. This product, designed for bowel preparation, is bioequivalent and therapeutically equivalent to Braintree […]
Strides Pharma Science Limited has announced a significant achievement, with its wholly-owned subsidiary, Strides Pharma Global Pte. Limited in Singapore, receiving approval from the United States Food & Drug Administration (USFDA) for Efavirenz (600mg), Emtricitabine (200mg), Tenofovir Disproxil Fumarate (300mg) tablets, abbreviated as EET. This approval marks another milestone in Strides’ growing portfolio of products […]
Strides Pharma Science Limited (Strides) announced that its Singapore-based stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (FDA). The tentative approval, which deems the Dolutegravir 50mg tablets bioequivalent and therapeutically equivalent to Tivicay Tablets of ViiV Healthcare Company, […]
In a major coup for Strides Pharma Science Limited, the company’s stepdown wholly-owned subsidiary, Strides Pharma Global Pte. Limited in Singapore, has scored approval from the United States Food & Drug Administration (FDA) for its Sevelamer Carbonate for Oral Suspension USP, 0.8g and 2.4g. The approval secures Strides Pharma’s position in the Sevelamer Carbonate market, […]
Strides Pharma Science Limited has announced a significant win as its Singapore-based wholly owned subsidiary, Strides Pharma Global Pte. Limited, has received United States Food & Drug Administration (FDA) approval for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL. The product is bioequivalent and therapeutically equivalent to CellCept for Oral Suspension by Roche Palo Alto, […]
Strides Pharma Science said that its biologics arm Stelis Biopharma has secured an establishment inspection report (EIR) from the US Food and Drug Administration (FDA) pertaining to the commercialization of drug-device combination products at its Bengaluru facility. Stelis Biopharma is an Indian contract development and manufacturing organization (CDMO). Strides Pharma Science said that the abbreviated […]
Strides Pharma Science has secured approval for Potassium Chloride Oral Solution USP, 40 mEq/15mL (20%) from the US Food & Drug Administration (FDA). The approval was bagged by the Indian pharma company’s step-down fully-owned subsidiary — Strides Pharma Global Pte. Limited, Singapore. The approved product is the generic of Genus Lifesciences’ Potassium Chloride Oral Solution […]