The First WHO GMP Accreditation for Penicillin Plant and Sterile Preparations Plant of PT SANBE FARMA in Indonesia
Posting date : 28 July 2017
In June 2017, PT SANBE FARMA has been accredited for Good Manufacturing Practice by World Health Organization (WHO) for two of its state of the art facilities, Penicillin Plant and Sterile Preparations Plant. PT SANBE FARMA is the first company to get this accreditation by WHO in Indonesia.

WHO is one of the most stringent approvals. WHO audits were conducted intensively and comprehensively for Penicillin Plant and Sterile Preparations Plant of PT SANBE FARMA, including Good Manufacturing Practice parameters such as but not limited to Production, Qualification, Validation, Quality Control, Quality Assurance, Sanitation & Hygiene, Personnel and Documentation in line with WHO GMP standards.

The Qualified Products:
1. AMOXSAN® (Amoxicillin Dispersible Tablet 250 mg) produced in Penicillin Plant.
2. SANTOCYN® (Oxytocin Injection 10 IU/mL) produced in Sterile Preparations Plant.

For SANTOCYN® PT SANBE FARMA's Sterile Preparations Plant is the first generic approval by WHO Prequalification Team and is Pre-qualified.

The accreditation from WHO could be accessed in below link:

Based on above achievement, SANBE is enable for UNICEF and UNGM Supply and become a part of Global Drug Facility (GDF) to support WHO-Global Health Program.