Certifications

2022

2021

2020

Integrated Management System certification by TÜV Rheinland.

2019

2018

2017

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