Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials

Lupin receives tentative approval from USFDA for Tolvaptan Tablets

Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)

Cosmo and Glenmark sign distribution and license agreements for Winlevi in Europe and South Africa

Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries

USFDA delegation visits Amneal Pharmaceutical facility in Matoda

Amneal’s site in Matoda is one of the company’s 12 pharmaceutical manufacturing facilities

Lupin receives USFDA approval for Pirfenidone Capsules

Pirfenidone Capsules had estimated annual sales of USD 95 million in the US

Lupin receives approval from USFDA for Pirfenidone Tablets

This product will be manufactured at Lupin's Pithampur facility in India

Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities