Alembic receives USFDA final approval for Paliperidone ER tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia

Lupin receives USFDA approval for Bumetanide Injection

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.

Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis

This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally

Strides receives USFDA approval for Fluoxetine Tabs 60 mg

Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices

USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington

Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding

Granules India’s Gagillapur facility completes USFDA inspection with six observations

The recent inspection covered both cGMP and PAI processes

Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug

Alembic Pharmaceuticals receives USFDA final approval for Albendazole Tablets USP, 200 mg

Biocon Pharma receives USFDA approval for daptomycin

The approval further adds to Biocon’s portfolio of complex drug products