The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route
The biosimilar Ustekinumab has been developed and manufactured by the company
The facility is equipped with state-of-the-art technology to produce high-quality lyophilized (freeze-dried) products
Smeeta Bhatkal, Santosh Desai and Akshay Kumar join as Independent Directors; Shaina NC as Non-Executive Director
Karkinos is in the business of providing technology-driven, innovative solutions for the early detection, diagnosis, and management of cancer.
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
This approval is a significant achievement in expanding the availability of this critical therapeutic,
Merck will record a pre-tax charge relating to the upfront payment of $588 million
SPARC to receive 55% equity in Tiller Therapeutics
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