News | October 14, 2024
Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP
Wockhardt's yet another novel antibiotic Miqnaf receives favourable recommendation from Subject Expert Committee of CDSCO
Wockhardt's yet another novel antibiotic Miqnaf receives favourable recommendation from Subject Expert Committee of CDSCO
Aims to achieve CDMO sales of US$ 400 million by 2028
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
The inspection conducted by EDQM at its Visakhapatnam facility
The inspection concluded with the issuance of a form 483 with five observations
This approval reflects company’s unwavering commitment that the quality assurance
Fermenta Biotech’s API manufacturing facility receives EU GMP compliance certificate
She brings an overall Techno Commercial experience of 22+ Years in various Organizations
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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