Supply Chain | December 14, 2022
BSV receives exclusive marketing and distribution right for NexoBrid in India
To focus on providing safer burn treatments for women and armed forces
To focus on providing safer burn treatments for women and armed forces
Diclofenac Sodium Topical Solution, 2% w/w (RLD PENNSAID) had estimated annual sales of US $509 million in the US (IQVIA MAT October 2022)
The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
The IPO is a complete OFS by existing shareholder Helix Investment Holdings
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
This product is based on Osmotic Controlled Release Oral Delivery System technology
40,000 visitors and representatives of more than 80 countries set to visit the show
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
The company sees the business reaching $100mn
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