The first EU GMP Audit successfully completed.
Caplin Steriles is a R&D driven company focused on the development and manufacturing of high quality Injectables and Ophthalmic products for Regulated Markets. The company has an excellent track record of quality compliance, developmental capabilities and enduring partnerships. At Caplin, we follow a hybrid mix of internal developments and filings and partnerships with external companies on a CDMO basis. The company constantly invests into newer technologies and capacities which include Injectables in Vials, Lyophilized Vials, Pre-Mixed Bags, Prefilled Syringes, Long Acting Suspension and Emulsion Injectables and Ophthalmics. Caplin Steriles is a subsidiary of fast growing Pharmaceutical company Caplin Point Laboratories Ltd.
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
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:
Started construction of Manufacturing Facility and R&D.
The first EU GMP Audit successfully completed.
Successful completion of first EU-GMP audit.
Successful completion of first EU-GMP audit.
Successful completion of first Brazil – ANVISA audit.
Successful completion of first Brazil – ANVISA audit.
Successful completion of first US FDA audit.
Successful completion of first US FDA audit.
First ANDA approved for a product developed and filed from Caplin.
First ANDA approved for a product developed and filed from Caplin.
First commercial exports to the US.
Successful completion of second US FDA audit, with Zero 483s.
Successful completion of second US FDA audit, with Zero 483s.
Fidelity Inc’s Eight Roads and F-Prime Ventures invests into Caplin Steriles for minority stake.
Successful completion of third US FDA audit.
Capacity expansion including capabilities to manufacture Emulsions and Suspensions installed.
A first generation entrepreneur, C.C.Paarthipan’s stint in the Pharmaceutical industry goes back ... Mr. Vivek Partheeban - Joined Caplin Point Laboratories Limited, the holding company, in 2005 and headed ... Dr. Sridhar Ganesan has over 35 years of varied global leadership experience in the Pharmaceutical Industry, ... Dr. C K Gariyali, aged 72, is a retired IAS officer and holds a Doctorate in ... Prem Pavoor is Head of India for Eight Roads Ventures, a proprietary global investment firm ... Adept at simultaneously balancing several successful careers in the spheres of technology, innovation, entrepreneurship and ... Ketan Patel, MD/MBA, is a Partner at F-Prime Capital, specializing in healthcare investments. With ... Ambassador Viswanathan is “Passionate about Latin America”. He blogs, tweets, writes articles, publishes books, gives ...Mr . C.C Paarthipan
Mr. Vivek Partheeban
Dr. Sridhar Ganesan
Dr. C K Gariyali, IAS
Dr. Prem Pavoor
Dr. KC John
Mr. Ketan Patel
Mr. R. VISWANATHAN
No of ANDAs Filed | 19 |
No of ANDAs Approved | 11 |
Working on overall pipeline of ANDAs to be filed in next 4 years | 34 |
No of PhD scientists at our R&D | 21 |
No of R&D Labs | 4 |
Overall market size of products in our pipeline (In Billions) | 2.71 |
Varied Delivery System Capabilities
This is to inform you that ANVISA- Brazil conducted an inspection of Caplin Steriles’…
Read More »This is to inform you that the United States Food and Drug Administration (US…
Read More »Chennai, Aug 08, 2024: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories…
Read More »Chennai, JULY 19, 2024: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories…
Read More »Interview by VIVEK PAARTHIPAN – COO Caplinpoint Laboratories Limited for CNBC-TV18 – Chartbusters programme.
Interview Date: 11th August 2020
Caplin Steriles has forged long term partnerships with Multinational companies from both US and ROW markets, and is constantly on the lookout for establishing more such relationships. Our hybrid business models include CMO, Co-Development and Outlicensing of our ANDAs to partners all over the globe.
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Caplin Steriles Limited, a subsidiary of fast growing pharmaceutical company Caplin Point Laboratories Ltd, specifically targeted towards regulated markets for Injectables and Ophthalmics.
+91 44 2496 8000
Caplin Steriles Ltd. 1st Floor, Ashvich Towers, No 3, Developed Plots Industrial Estate, Perungudi, Chennai 600096. Tamil Nadu, India.