Caplin Steriles Ltd.

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

• Product development aimed to meet various global regulatory agencies – One Global Quality Dossier.
• Development of different types of dosage forms which includes injectables and ophthalmic products.
• Develop various injectable dosage forms like solutions, lyophilized products, long acting sterile suspensions, parenteral micro/ nano emulsions, etc.
• Develop various Ophthalmic dosage forms like solutions, sterile suspensions, nano ophthalmic emulsions.
• New product development in Bags as Large Volume Parenteral, which has the ease of using in patients directly as “Ready to Use”.
• Development of various analytical techniques to evaluate and characterize the conventional and long acting NDDS type products.
• Development and validation of all the analytical methods required for the products developed and also support to QC in transferring those methods at manufacturing site.
• Support to regulatory department in compiling documents required for dossier submission.

Manufacturing

• With our proven performance in simple and complex injectables across development, manufacturing, we are enabled to meet diverse injectable needs. Currently, 3 production lines for finished formulations to augment the present manufacturing capacity of approximately34 million units in vials and 7 million units in ophthalmic to support future growth.
• We have in house Quality control and microbiology laboratory fully equipped to analyze the raw materials, packing materials and finished product.
• Our Quality systems and procedures are designed to meet the requirements of developed markets of USA, Europe and Brazil. We commit to continuous improvements of our quality systems through education of our employees and by investing in automations whereverpossible.

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:

• Our Intellectual Property Rights team interdisciplinary approach is tailored to suit organizational business and strategic objectives. Our Intellectual Property Rights team foresee the product filing timelines by starting with the assessment of patent landscape, continuing through strategy and litigation as an end-to-end process to support the organizations business objectives.
• Our Intellectual Property Rights team closely track the competitive landscape and dynamic global pharmaceutical marketplace for each and every product, identify and further pursue market opportunities without delay to meet organizational objectives and bringing the generic product in to the market to meet healthcare demands.
• Our Intellectual Property Rights team is distinguished by a high degree of technical and scientific expertise in understanding Hatch-Waxman Litigation and providing consistent inputs to support organizational business objectives.
• Our Intellectual Property Rights team effectively and strategically work with the R&D team in creating IP assets to the organization.