USFDA completes inspection at APL HealthCare

The company has been issued ‘Form 483’ with two observations

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults

Zydus receives final approval from the USFDA for Febuxostat Tablets

Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).

Lupin receives approval from USFDA for Prasugrel Tablets, USP

Dr. Mandaviya inaugurates Annex Building of ICMR-RMRC, Bhubaneswar

The centre has initiated next generation sequencing (NGS) as a tool for undertaking studies on genomic epidemiology of pathogens

Lupin receives approval from USFDA for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz®) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).

Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma

Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.

Polysciences announces new bioprocessing brand ‘Kyfora Bio’

Kyfora Bio will focus on the synthesis of cationic polymers, lipids, and other materials used in nucleic acid delivery for cell and gene therapies.

Granules partners with Greenko ZeroC to enable green molecule solutions

Greenko ZeroC will supply Carbon Free Energy and enable Green Hydrogen along with its various chemical derivatives.