Drug Approval | August 27, 2021
Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The company has to approach the DCGI for approval to commence the trials
The clinical research organisation located in Hyderabad is a USFDA inspected facility
The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
First results demonstrate favourable tolerability of TQL-1055 at all dose levels
The investment will establish drug product manufacturing capacity for clinical trial and commercial supply in China and offer customers combined drug substance and drug product manufacturing services
The co-investment of CHF 4 million will result in capacity expansion and support the market introduction of the customer's lead compound
Viraleze was developed for application in the nasal cavity to help reduce exposure to respiratory viruses, including SARS-CoV-2. The product is registered for sale in Europe and India, and available online in certain markets
It is the first branded generic alternative to Fostair 100/6 pMDI
CDSCO gives the green signal as HGCO19 was safe, tolerable and immunogenic in the participants of the study
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