Caplin Point Laboratories Ltd

MANUFACTURING FACILITIES

CP-I

Caplin Point Laboratories Ltd Unit-I (CP-I) is a WHO-GMP approved facility, situated in Suthukeny, which is about 20 km from Puducherry.

The company has the facilities to manufacture :

Sterile Penem Injectables
Tablets
Capsules
Liquid Orals (Syrup & Suspension)
Soft Gelatin Capsules
Dry powder for Oral Suspension
Suppositories and Ovules

Location : Suthukeny, Puducherry

CP-IV

Caplin Point Laboratories Limited, Unit – IV (CP-IV) is a US FDA, EU-GMP, ANVISA and INVIMA approved manufacturing facility handling Pharmaceutical formulations in Specialized Injectable dosage forms and Ophthalmic drops. The facility is designed with a high level of sophistication and automated process control and is in compliance with norms stated by US FDA, UK MHRA and other regulatory bodies belonging to PIC/s.

The Site has a dedicated facility for formulation development, analytical development and stability department for product development in sterile dosage forms.

CP-IV is capable of handling general category and specialized category injectable dosages in Vial, Ampoules, Lyophilized Vials and Ophthalmic dosages.

The plant capacity is :

Ampoules : 25 Million units per annum
Vial : 25 Million units per annum
Lyophilized Vials : 1.2 Million units per annum
Ophthalmics : 12 Million units per annum

Location : Gummidipoondi, Chennai

CP- LL1

Caplin Point Laboratories LL-1 is a WHO-GMP approved facility, situated in Chennai.

The company has the facilities to manufacture:

Tablets (β-lactam and non β-lactam)
Capsules (β-lactam and non β-lactam)
Liquid Orals (Syrup & Suspension) (Non β-lactam)
Dry powder for Oral Suspension (β-lactam and non β-lactam)

Location : No. 3, Multi Industrial Nagar, Gerugambakkam,Chennai - 602 128.

CP- LL2

Caplin Point Laboratories LL-2 is a WHO-GMP approved facility, situated in Baddi, Himachal Pradesh. .

The company has the facilities to manufacture:

Sterile Powder for Injections (β-lactam and non β-lactam)

Location : Plot No.4, Village Kunjhal, Near Jharmajri,, Baddi, Distt. Solan, Himachal Pradesh – 173205.

RESEARCH & DEVELOPMENT

Caplin Point has 2 DSIR approved dedicated R&D setups with capabilities to develop safe and effective formulations. Caplin Point has a team of over 100+ scientists working on development of varied dosage forms such as Injectables, Soft Gelatin Capsules, Suppositories, Tablets, Capsules, Semi-solids and Liquid orals.

Separate teams work on formulation development and analytical studies of molecules for Regulated and Emerging markets. R & D scale stability studies, forced degradation studies, method development and validations are carried out in house. The Caplin R&D teams continue to grow in strength each year, taking on complex challenges across varied formulations.

CP-II (Gummidipoondi)

A dedicated pharmaceutical R&D facility located at Gummidipoondi with capabilities to develop safe and effective formulations.

Sophisticated facility and resources to develop dosage forms like Tablets, Capsules, Semi-solids (including suppositories), Liquid orals, Granules and Soft Gelatin Capsules.

Separate teams for formulation development and analytical development.

R & D scale stability studies, forced degradation studies, method development and validations are carried out in-house.

The following range of services are provided :

Design and development of new dosage forms as per customer needs
Process improvements and optimization
Stability studies as per ICH guidelines
Analytical development and Method validations as per ICH guidelines
Technology transfer of new developed formulations
Dissolution profiles as per CDER/EU guidelines

Scope of Services

Bioequivalence studies are conducted in healthy human volunteers for Generic Pharmaceutical companies from India and Abroad
For certain classes of drugs like cytotoxic and psychotropic drugs, BE studies can be done only on appropriate patients. These studies will be executed at hospital sites and centrally controlled by Mahindra City facility
In some cases of generic drugs, the bioavailability cannot be demonstrated in blood samples. Hence a clinical Endpoint is used to demonstrate equivalence to the innovator product
Phase II to Phase IV Clinical trials for IND/NCE

USPs of Amaris Clinical CRO

Automated plasma sample storage and management system
Fully automated liquid handling system
Technologically advanced volunteer tracking and management system
Comprehensive eCRF platform
Technologically advanced nurse calling system
Continuous vital signs monitoring system
State of the art Intelligent Building Management System
Watson LIMS
Sophisticated and dust free BA-LCMS room
5 star clinical bed facility

R&D Capabilities: CP-V (Perungudi)

CP-V Unit; R&D-3 is located in Perungudi, Chennai
CP-V approved by Government of India, Department of Scientific and Industrial Research (DSIR).
Working on wide range of products covering Injectables – Liquid Injectables (both vial and PFS presentation), Ophthalmic products and Lyophilized products etc.
Working on complex Injectables like Liposomes, Peptides, Suspensions, Emulsions etc.
Working on Regulated markets like US, Europe and Brazil
Having a strong team working on areas relating to Formulation Development, Analytical Development, Technology Transfer, Quality Assurance, Strategic Sourcing, Dossier Preparation and Regulatory Filings
Capabilities to build and maintain a strong product pipeline together with the regulatory strengths, have resulted in quick registrations in regulated markets.

GLOBAL INFRASTRUCTURE

Caplin Point is headquartered in the Southern Indian city of Chennai, with close access to its manufacturing units and the Chennai seaport. Corporate team of 110+ personnel handle various areas from Finance, Administration, Regulatory, HR, PPIC, Supply Chain and Corporate QA from Chennai.

Caplin Point has branches and subsidiaries established in China and Hong Kong, and is in the process of establishing more subsidiaries in Colombia and other locations, as part of its expansion strategy.

MANUFACTURING FACILITIES

CP-I

The company has the facilities to manufacture :

CP-IV

The plant capacity is :

CP- LL1

The company has the facilities to manufacture:

CP- LL2

The company has the facilities to manufacture:

RESEARCH & DEVELOPMENT

CP-II (Gummidipoondi)

A dedicated pharmaceutical R&D facility located at Gummidipoondi with capabilities to develop safe and effective formulations.

Sophisticated facility and resources to develop dosage forms like Tablets, Capsules, Semi-solids (including suppositories), Liquid orals, Granules and Soft Gelatin Capsules.

Separate teams for formulation development and analytical development.

R & D scale stability studies, forced degradation studies, method development and validations are carried out in-house.

The following range of services are provided :

Scope of Services

USPs of Amaris Clinical CRO

R&D Capabilities: CP-V (Perungudi)

GLOBAL INFRASTRUCTURE

CONTACT US

Corporate Office

Registered Office

USEFUL LINKS

LIFE AT CAPLIN POINT