The company Adipharm has a modern pharmaceutical factory located in the capital of Bulgaria – Sofia. The Company manufactures solid dosage forms such as tablets, film-coated tablets, capsules and powders for oral use.  The work is carried out with a focus on drugs for treatment of cardiovascular system, nervous system, alimentary tract and metabolism and OTC preparations.  Production site is equipped with a modern high quality machines and devices that satisfy latest GMP requirement for quality production.

Additionally, Adipharm is expanding its production capacities. In 2011 Adipharm Ltd production side was fully modernized. The company  introduced a new sachet filling machine, new high speed mixer granulator of latest generation, and a new coating machine.

The production capacity for solid forms is more then 1,3 billion units per year.

The first Marketing Authorization of Adipharm was issued on Sept 10th, 2013. The MA allows the company to manufacture and package solid dosage forms.

In 2017, the Manufacturing Authorization is expanded and now includes the following dosage forms:

✓ Tablets;

✓ Hard Capsules;

✓ Coated Tablets;

✓ Sachets of powders;

✓ Sachets of liquid for oral use;

✓ Ampoules and Injections – second packaging;

✓ Soft Capsules – packaging.

GMP

Good Manufacturing Practice (GMP) is an EU and worldwide standard. Its objective is to ensure  the cleanliness, safety and high efficacy of medicinal products, medical devices and processes in place within the company.
GMP standards apply to the manufacturing process, staff qualifications, archiving analytical results and control and distribution processes. The system is based on three pillars: first: procedures, second: training, third: internal audits. Only when all of the three modules are in place the system is deemed fully implemented.

CERTIFICATES

Adipharm has received the following certificates:

European Certificate of GMP compliance of a manufacturer: № BG/GMP/2011/022

– Manufacturing/Import authorisation for medicinal products: P-I-13 004