API
COBAPHARMA, through its exclusive partnerships, manufactures APIs in selected cGMP facilities with the highest level of compliance, audited by major Regulatory Authorities (FDA, EDQM, TGA, PMDA, etc.)
We are committed to assist you during the development, filing and commercialization of your products by means of our partners R&D, QA, QC and regulatory teams.
Moreover, we offer logistic services such as import/export activities, as well as product storage.
As an important part of the supply chain, we coordinate the logistics services ensuring GDP compliance, from origin to your facilities, including storage if required.
Finished Dosage Form
COBAPHARMA offers full range of premium dossiers from tech transfer to ready for filling. Our portfolio offers different forms, providing innovative products to assure the best-selling entry into the market.
Our experts will provide customized regulatory assistance to guarantee a successful registration.
Innovation and development is our commitment with the pharmaceutical industry; for that reason COBAPHARMA’s portfolio is constantly updated developing state-of-the-art dossiers.
Registration and Distribution in China
China, the largest emerging country in the world, is a fast growing pharmaceutical market where to be.
However, the entrance to this market is a challenge due to the strict and changeable regulation to overcome, the vast territory and the fragmented distribution channels.
Our strong knowledge and experience in Chinese market together with our local Joint Venture, makes COBAPHARMA your preferred partner to enter in China.
We introduce and export selected APIs and FDFs into the Chinese market, taking care of:
- Market analysis
- Documentation review
- Dossier compilation
- Filing procedure
- Bioequivalence studies
- API registration nº attainment
- Customers identification
- Sales and Market distribution