While global harmonization exists, there are still differences between the US and European GMP requirements that ...

As such, scientists and engineers look for ways to improve and streamline CGT production workflows, including using good manufacturing practices (GMP)-grade materials and reagents from ...

The US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6 - 17, the Mumbai-based drug firm said ...

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a ...

March 31, 2025 /PRNewswire/ -- DDL, a leading provider of package, product, and material testing services, is pleased to announce the opening of a new Good Manufacturing Practice (GMP) laboratory ...

On conclusion of the inspection, the Subsidiary has received One (1) inspectional observation in Form 483. There is no data integrity observation. The Subsidiary will work closely with the USFDA and ...

Gujarat FDCA trains 900 MSMEs to submit gap analysis documentation as per revised Schedule M: Shardul Nautiyal, Mumbai Friday ...

and commercial good manufacturing practice (GMP) manufacture, has obtained its first drug manufacturing license (DML) from China’s National Medical Products Administration (NMPA) (1). “This ...

including violation of current good manufacturing practice (CGMP) regulation, at its Ahmedabad-based plant. In a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug ...