Regulatory Approvals
Over the years Beximco Pharma has established itself as a trusted source for prescription and OTC drugs. It always strives for quality, not only in the finished products but also in the manufacturing process itself. Beximco Pharma’s manufacturing facilities have undergone satisfactory audits by global regulatory bodies and thus have been awarded regulatory approvals including:
- GMP clearance from Therapeutic Goods Administration (TGA) Australia for OSD, MDI and Spray.
- GMP certification from Gulf Central Committee for Drug Registration, Executive Board of the Health Ministers’ Council of GCC states.
- GMP certification from ANVISA, Brazil (Agência Nacional de Vigilância Sanitária)
- GMP certification from INVIMA, Colombia (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)
- GMP certification from AGES, Austria (Austrian Agency for Health and Food Safety)
- Qualified by UNICEF (MDI & OSD)
- Qualified by Asthma Drug Facility (ADF), France (MDI)
GMP accreditation audit by an EMA regulatory authority was completed for the OSD and Ophthalmology units, and inspections and approvals from UK MHRA and US FDA are anticipated.