Asahi Kasei Pharma obtains approval to manufacture and sell Cresemba Capsule 40 mg as additional formulation in Japan
The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg
The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg
MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
Aragen Life Sciences is the first Indian CRDMO to receive SBTi approval
Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules
The company will now seek final approval from NCLT, Mumbai Bench, and upon its receipt, OneSource will proceed to seek listing approvals from the BSE and NSE
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
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