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The manufacturing in compliance with Romanian law no 95/2006 regarding medicines for human use. Valid Manufacturing Authorization, in full compliance with GMP issued by the National Medicine and Medical Devices Agency. The authorized manufacturing operations include: The total and partial manufacture (different processes of dispensing, packaging or presentation are included), certification and batch release, import, storage and distribution of: Sterile products, aseptically prepared- small volume liquids- eye drops (monodose and multi-dose solutions and suspensions) parenteral solutions in ampoules, prefilled syringes, vials and freeze dry products in vials. Sterile products terminally sterilized- small and large volume parenteral solutions in prefilled syringes and vials. Non sterile products. Capsules. External use liquids. Internal use liquids. Other dosage forms: powders and granules (single-dose and multi-dose in sachets and bottles), film coated tablets. Tests (microbiological and physical-chemical) for quality control. Manufacturing operations for investigational medicinal products include total or partial, certification and batch release, import, storage and distribution and tests (microbiological and physical-chemical) for quality control for: Rompharm Company holds marketing Authorization for most of the products manufactured on site and acts as contract giver and contract acceptor for some medicines. |
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