Certifications
2019
Integrated Management System certification ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 by TÜV Rheinland.
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
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
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.
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
