Services
In/Out Licensing
Licensing Models for Rapid Growth
At Rompharm Company, we offer comprehensive licensing packages for our approved pharmaceutical products, which are available in regions where the active ingredients are already authorized. We manage manufacturing and provide regulatory support to our partners who handle the registration and marketing in their territories.
Our Licenseing Services
– Provision of approved products
– Global dossiers based on EU standards
– High-quality pharmaceutical production
– Market-specific packaging
– Maintenance of marketing authorization and ongoing improvements
Licensable Products
We have a range of products available for licensing. For in/out-licensing inquiries, please contact our licensing department at: export@rompharm.ro
Contract manufacturing
The manufacturing complies 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.
Rompharm Company holds Marketing Authorization for most products manufactured on-site.
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-dried products in vials.
– Sterile products terminally sterillized - 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)
– Tests (microbiological and physical-chemical) for quality control.