Zydus receives final approval from the USFDA for Pitavastatin Tablets

Briefs: Alkem and Krsnaa Diagnostics

Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.

Piramal Pharma starts production at new API facility in Riverview, Michigan

New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)

Briefs: Neuland Laboratories, Cipla and Zydus

Cipla has received 8 inspectional observations in Form 483

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States

Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg

Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)

Briefs: Piramal Pharma, Alembic Pharmaceuticals

USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA

GUERISON enters Indian Ophthalmology market

The company has launched its new range of 25 allopathy ophthalmic products including GUERIMOD, GUERIPRED, BIMATO MST etc. for curing various diseases related to eyes

Zydus receives tentative approval from the USFDA for Canagliflozin tablets

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

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)