Drug Approval | August 31, 2023
Lupin receives USFDA approval for Pirfenidone Capsules
Pirfenidone Capsules had estimated annual sales of USD 95 million in the US
Pirfenidone Capsules had estimated annual sales of USD 95 million in the US
Prasugrel tablets are indicated to reduce the rate of thrombotic CV events
This product will be manufactured at Lupin's Pithampur facility in India
The company has entered into a three-year Deferred Prosecution Agreement
The deal represents a total transaction value of up to $36 million with an initial upfront consideration of $14 million
Weinand is the former CEO and Chairman of the Board at Bayer Pharma AG, leading Bayer’s fully integrated $20 billion healthcare business
Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)
The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
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