Zydus receives final approval from the USFDA for Pitavastatin Tablets

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)

Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg

According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million

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)

Zydus receives tentative approval from the USFDA for Canagliflozin tablets

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

Lupin receives approval from USFDA for Glycopyrrolate Injection USP

The approval for Glycopyrrolate clears the path for more internally manufactured injectable products

Alembic Pharmaceuticals Q3 FY23 revenue up 19% to Rs. 1,509 Cr

Net sales for 9M FY23 up 9% to Rs. 4,246 crore and net profit for 9M FY23 at Rs. 189 crore

Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US

The Durezol brand and generic had US sales of approximately US $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA