Regulatory
Welcome to Alkem Activa's Regulatory Department, where our unwavering commitment to compliance, quality and global standards is the driving force behind our pharmaceutical excellence. Our regulatory team ensures that every product we produce adheres to stringent regulations, safeguarding the well-being of patients. The quality of our submissions meets the ICH standards of eCTD.
In the pharmaceutical industry, regulatory adherence is the bedrock of quality, safety and efficacy. At Alkem Activa, our approach is rooted in pioneering compliance and quality. We understand that regulatory excellence is the cornerstone of delivering safe and effective healthcare solutions.
Alkem Activa boasts a portfolio of over 40 U.S. Drug Master Files (US DMF's), a significant milestone that showcases our expertise in meeting the global regulatory expectations. These US DMF's represent our commitment to meeting the stringent requirements of the U.S. Food and Drug Administration (USFDA) and global regulatory authorities like European Medicine Agency (EMA), Ministry of Food and Drug Safety (MFDS), Korea and Therapeutic Goods Administration (TGA), Australia.
2013- Facility found to be compliant
- Facility found to be compliant
2015- EIR received
- Facility found to be compliant
2021- Facility found to be compliant
- Facility found to be compliant
- Facility found to be compliant
2023- EIR received with no observations
Note: Written confirmation (WC) certificate is available for both the facilities
