Certifications
2022
- Due to the restrictions caused by COVID-19, the period of validity of GMP certificates is automatically extended until the end of 2022, as also specified in EudraGMDP database
2021
2020
Integrated Management System certification by TÜV Rheinland.
- Occupational health and safety management ISO 45001:2018
- Environmental management ISO 14001:2015
- Occupational health and safety management ISO 45001:2018
2019
- GMP Recertification for the parenteral products manufacturing
- GMP Recertification for Nystatin active ingredient
- GMP recertification for veterinary products (parenteral products, ointments) by ANSVSA Romania
2018
- GMP Audit conducted by the National Agency for Medicines and Medical Devices (ANMDM) for the recertification on the manufacture of ointments, creams, gels and suppositories.
- Renewal of the Certificate of Suitability (CoS) for Nystatin API
*First CoS authorization took place in 2005 - SRAC Recertification for the compliance of aluminum tubes and caps manufacture.
- SRAC Recertification for the compliance of aluminum tubes and caps manufacture.
- SRAC Recertification for the compliance of aluminum tubes and caps manufacture.
2017
- GMP Audit conducted by the National Agency for Medicines and Medical Devices for the recertification of the following manufacturing flows: tablets, capsules, ointments, creams, gels and suppositories
- US FDA inspection for Nystatin active ingredient and parenteral products
- Good Laboratory Practice (GLP) recertification of the Bioanalytical Laboratory in the Center for Drug Evaluation.
*The first GLP certification was in 2006 - Good manufacturing practice (GMP) recertification for the manufacture of Investigational Medicinal Products (IMPs).
- Certificate of GMP Compliance of a manufacturer Part 1 & 2
2016
- GMP Recertification for the parenteral products manufacture
- GMP Recertification for Nystatin active ingredient
- GMP recertification for veterinary products (parenteral products, ointments and Nystatin feed-grade) by ANSVSA Romania
2015
- US FDA Re-approval for Nystatin active ingredient and parenteral products
- GLP recertification of the Center for Drug Evaluation and monitoring compliance to GCP and GMP norms with respect clinical studies.
*The first GLP certification was in 2006
2014
- GMP Audit conducted by the National Agency for Medicines and Medical Devices and WHO (World Health Organization) for the recertification of the following manufacturing flows: tablets, capsules, ointments, creams, gels and suppositories
- Inspection of the tablet manufacturing line by Smart Pharmaceutical on behalf of the National Authority of South Africa
- SRAC Recertification for the compliance of aluminum tubes and caps manufacture
2013
- GMP Recertification for the parenteral products manufacture
- GMP Recertification for Nystatin active ingredient
- US FDA Re-approval for Nystatin active ingredient and parenteral products
- WHO prequalification inspection for anti-TB drugs
- GMP Inspection on behalf of the Ministry of Health in Libya on the following manufacturing lines: tablets, capsules, ointments, suppositories and parenteral products
2012
- Joint inspection NAMMD – PIC/S for the manufacturing flow of parenteral products
- GMP recertification for veterinary products (parenteral products, ointments and Nystatin feed-grade) by ANSVSA Romania
2010
- Renewal of the Certificate of Suitability (CoS) for Nystatin API
*First CoS authorization took place in 2005
2008
- GMP inspection conducted by Al Hobail Medical Center, Saudi Arabia on the manufacture of capsules, parenteral products, tablets
2007
- Environmental Management System and Occupational Health and Safety Certifications
- FDA re-approval for Nystatin API
2005
- ISO 9001 Certification for the Quality Management System
2002
- GMP authorization for the Ointments and suppositories manufacture
- FDA re-approval for Nystatin API
2001
- GMP Certification for Nystatin active ingredient (API)
2000
- GMP certification for the tablet manufacturing line
- GMP audit on behalf of UNICEF
1999
- GMP certification for the capsule and parenteral products manufacturing lines
