The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
India's bio economy has experienced remarkable growth, skyrocketing from $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
The company has received the GMP Certification after successful closure of the inspection
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
This product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients
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