Indoco’s clinical research organisation ‘AnaCipher’ completes USFDA inspection

Zydus receives final approval from USFDA for Ketoconazole Shampoo, 2%

Ketoconazole shampoo is an antifungal medication used to treat dandruff

Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis

The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara

Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US

There are 38.4 million people with diabetes in the United States

Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals

USFDA inspection at Alembic Pharma's Bioequivalence facility

Zydus receives final approval from USFDA for Dasatinib Tablets

Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase

Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility

The company will provide the necessary response on these observations to USFDA within stipulated 15 days

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity

Briefs: Emcure and Relonchem

USFDA inspection at Emcure Pharmaceuticals API facility

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure