Stelis Biopharma’s flagship facility receives EIR from USFDA
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company will respond to these observations within the stipulated time period.
Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
Partnership to leverage the Helix Laboratory Platform and QIAGEN's biopharma relationships, NGS capabilities, and global regulatory expertise
Dr. Jain is a biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, AbbVie, Abbott Laboratories, and G.D. Searle and Co
Purchase agreement with ViewRay will make state-of-the art precision radiation therapy available in China
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