Enaltec has evolved in its business strategies with the supply of its API business to the semi-regulated market (South East Asia, Latin America, etc.) and subsequently graduating to the supply of API’s to the regulated countries (USA and EU).
Enaltec now also offers clients its expertise in the area of formulation development and works with clients across the globe in the areas of contract research and development under various business models.
Enaltec provides a complete seamless package for a client, right from the API development and sourcing to the final dossier submission, in the respective regulated markets.
- Client agrees to a project cost under the agreed scope of work and the project cost is split into milestones which gets paid on achievement of the deliverables attached to the milestones
- The project is deemed complete after successful technology transfer of the product to the clients manufacturing site and/or successful Bio Equivalence
- Client compiles and files the dossier to the regulatory agencies
Turnkey / Co-development / Profit Sharing
- Financial Contribution to the Project by Enaltec
- Profits split after launch of Product in the ratio of investment
- Backward integrated projects with API of interest in this model
The services which Enaltec provides under turnkey are the following:
- Enlatec is integrated backwards with its API development and manufacturing facility; hence can provide their own API or can support clients in procurement of API from other suppliers
- Enaltec has an in-house IPM team which takes care of the patent evaluation with respect to API / formulation
- The formulation R & D of Enaltec takes care of development of complex generic formulations; its analytical method development and validation
- Enaltec takes the responsibility of technology transfer of the formulation from its R & D facility to the preferred manufacturing partner or the client manufacturing site
- Enaltec’s Clinical monitoring team identifies and selects the sites for BA / BE studies and monitors the studies completely
- Enaltec’s regulatory team takes care of the complete dossier compilation and submission in their respective regulated market authorities