Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
With this QIP placement, the Dhanuka group, which took over the company in 2018, is also meeting its mandatory obligation to dilute 15 percent stake in the company by March 2023
Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
TPE tubing is ideal for pharmaceutical bioprocessing applications because it can be welded to existing tubing lines, and heat-sealed to allow for easy, fast, and safe fluid transport in biopharma processes
The laboratory has the capacity to conduct 30,000+ tests in a month ranging from simple routine tests to semi-specialized and specialized tests
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
This product is based on Osmotic Controlled Release Oral Delivery System technology
QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.
The focus of the companies in this partnership is to synergise capabilities, leverage research and bring innovative products in specific therapeutic areas
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