Zydus receives final approval from the USFDA for Minocycline Hydrochloride ER Tablets

The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.

USFDA approves Roche’s Columvi for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma

Lupin receives EIR from FDA for its API manufacturing facility in Vizag

The inspection closed with the facility receiving an inspection classification of NAI

USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

The inspection closed with zero observations

Bliss GVS Pharma updates on inspection by USFDA

The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities

Milla receives first cycle FDA approval for Dexmedetomidine Hydrochloride Injection

Zydus receives final approval from USFDA for Esomeprazole Magnesium

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)

Zydus receives final approval from the USFDA for Tadalafil Tablets USP

Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)