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


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