Caplin Steriles is a subsidiary of fast-growing Pharmaceutical company Caplin Point Laboratories Ltd, specifically targeted towards Regulated Markets for Injectables and Ophthalmics.
Our Strength
Research & Development
Caplin Steriles limited has a state of art Research and Development (R&D) facility for the development and characterization of various types of injectables and ophthalmic dosage forms. It comprises of a great team of scientists with strong technical knowledge and experience in the field of Novel drug delivery systems.
Our R&D team is involved in following activities
Manufacturing
RA&IPR
Regulatory Affairs:
Caplin is self-reliant on making end-to-end regulatory submissions for generic products in US. Appropriate regulatory advice is obtained from Agency through controlled correspondence for developing complex generic products. A robust review mechanism is in place to avoid any Refuse to Receive (RTR) situation. Product dossiers are compiled in-house in to eCTD modules using eCTD/eSPL software. Submissions are made to the Agency using Caplin’s Electronic Submission Gateway (ESG).
Received acceptance from Agency for Competitive Generic Therapies (CGT) and Priority Review assigned for few ANDA applications.
Intellectual Property Rights:
Sincerely Packaging Labelling
Regards,
Client Success Team (CRM),
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