This recertification of Company's OECD GLP is testimony to company's unwavering commitment to maintain international quality standards at the facility
By integrating Rockwell Automation’s FactoryTalk Optix, NKP Pharma has achieved compliance with USFDA 21 CFR Part 11
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
Strategies aimed at solving the current overdose epidemic must go beyond the identification of risk
The company was directed to submit a plan of compliance by July 15, 2022
Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)
The company has received a certificate of Good Manufacturing Practice compliance from the Medicines & Healthcare products Regulatory Agency (MHRA) UK
This certification validates the plant’s robust capabilities in manufacturing a wide range of sterile dosage forms
The inspection was conducted from July 22-25, 2025
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