Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
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
The focus of the companies in this partnership is to synergise capabilities, leverage research and bring innovative products in specific therapeutic areas
The joint venture will help both the parties to further develop the high-margin service business
South Asia’s largest exhibition for pharma brought together over 50,000 visitors from across the globe
Gland Pharma enters into a Put Option Agreement to acquire 100% of Cenexi Group
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