2017

US FDA inspection for Nystatin active ingredient and parenteral products

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

Integrated Management System re-certification by Lloyd’s Register Quality Assurance (ISO 9001: 2008, ISO 14001: 2004, OHSAS 18001: 2007)

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

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