Strides Pharma subsidiary gains FDA approval for EET tablets

Strides Pharma subsidiary gains FDA approval for EET tablets

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 receives FDA approval for Icosapent Ethyl Capsules

Strides Pharma receives FDA approval for Icosapent Ethyl Capsules

Strides Pharma Science Limited (Strides) has achieved a significant milestone by announcing the United States Food & Drug Administration (USFDA) approval of Icosapent Ethyl Capsules 0.5 gram and 1 gram. This approval comes through its wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore. The newly approved product seamlessly integrates into Strides’ portfolio of authorized […]

Strides Pharma’s HIV generic drug gets tentative FDA approval

Strides Pharma’s HIV generic drug gets tentative FDA approval

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, […]

Strides Pharma wins FDA approval for kidney drug Sevelamer Carbonate

Strides Pharma wins FDA approval for kidney drug Sevelamer Carbonate

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 gets FDA nod for Mycophenolate Mofetil, targets $145m market

Strides Pharma gets FDA nod for Mycophenolate Mofetil, targets $145m 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 gets FDA approval for Potassium Chloride Oral Solution generic

Strides Pharma gets FDA approval for Potassium Chloride Oral Solution generic

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 […]

Strides Pharma gets FDA approval for Cyclosporine Softgel Capsules

Strides Pharma gets FDA approval for Cyclosporine Softgel Capsules

Strides Pharma Science said that its stepdown fully-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured approval from the US Food and Drug Administration (USFDA) for Cyclosporine Softgel Capsules USP (Modified), 25 mg, 50 mg, and 100 mg. The immunosuppressant medication product is bioequivalent and therapeutically equivalent to Neoral Capsules 25 mg, 50 mg, […]