USFDA completes inspection of Lupin's Dabhasa facility with no observations

The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations

Asahi Kasei Bioprocess and Axolabs partner to accelerate oligonucleotide therapeutics development

The partners will collaborate to build a cutting-edge oligonucleotide cGMP manufacturing facility

NATCO Pharma receives warning letter from USFDA for facility in Kothur, Telangana

The company will respond to the Warning Letter within the stipulated timelines

Cipla Patalganga facility gets 6 USFDA observations

The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant

Warren Remedies commences commercial production of APIs

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483

Sharon Bio-Medicine resumes operations

Operations of Line II was stopped due to a fire incident earlier

Zydus receives tentative approval from USFDA for Letermovir Tablets

Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)

Zydus receives USFDA approval for Finasteride and Tadalafil capsules

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