Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA
The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore
The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore
The approval further strengthens the Potassium Chloride franchise for the company.
Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
Strides is the first Indian company to get approval for the product.
Manish led SeQuent since 2014 and played a major role in transforming the company
Both manufacturing facilities are based out of Benguluru, India
Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
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