Drug Approval | September 19, 2024
Lupin receives USFDA approval for Bumetanide Injection
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
Professor G. D. Yadav is one of India’s most prolific and accomplished engineering-scientists, holding the prestigious National Science Chair from the Government of India
Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Vonoprazan in India
Aragen Life Sciences is the first Indian CRDMO to receive SBTi approval
Sanofi would not manufacture or market any product which infringes the amended claims of Panacea patent, IN272351
This validation aligns with Piramal Pharma's core purpose of 'Doing Well and Doing Good,'
Total investment incurred for setting up the new R&D Rs 250 crore
The award is for development of Nafithromycin, which is the first ever multi-drug resistant pathogen active respiratory antibiotic for the treatment of Community-Acquired Bacterial Pneumonia
GPCB has also asked to submit a bank guarantee of Rs. 2, 00,000 for compliance assurance at the time of revocation and has also ordered to deposit interim environment damage compensation amount
The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
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