GMP and CTD standard

Open Joint Stock Company «Farmak» was the first ukrainian pharmaceutical company which production lines were certified by EU GMP inspection and the first which started to produce generic of Gadopentetat Dimeglumine the next day after finishing patent in cooperation with company Curagita (Germany). This product was registered in 22 EU-countries by DCP procedure.

We have cGMP Certificate by EU GMP inspection on the following production lines:

• production line for manufacturing of tablets (line for production of Validol);
• production line for manufacturing of ear/eye/nasal drops, sprays (Marchesini line);
• production line for manufacturing of sterile eye and sterile nasal drops (Bottle-pack line);
• production line for injectable preparations (Bosch line).

Other production lines have local GMP authorization.

We have registration dossiers, prepared according to the CTD standard for the following medical preparations:

• Validol (menthyl valerate);
• Farmadex (Dexamethazone) eye drops;
• Naphthyzine (Naphazoline Nitrate) nasal drops;
• Farmazolin (Xylomethazoline Hydrochloride) drops and sprays;
• Rhynazoline (Oxymethazoline) drops and spray.

We are preparing now CTD dossiers for the following medical preparations:

• Picolax (sodium picosulfate) drops;
• Pilocarpini hydrochloridum (Pilocarpinе) eye drops;
• Uropres (desmopresin) nasal drops and spray;
• Visiale (Tetryzoline) eye drops;
• Timolol maleatе (timolol) eye drops;
• Sulfacil sodium (Sulfacetamide) eye drops.