CP-I
Caplin Point Laboratories Ltd Unit-I (CP-I) is a Colombia-INVIMA and WHO-GMP approved facility, catered towards emerging markets of Latin America and Africa:
The facility has state of the art equipment manufacturing the following dosage forms:
- Sterile Liquid & Lyophilized Injectables
- Pre-Filled Syringes (Single & Dual-Chamber)
- Tablets
- Capsules
- Liquid Orals (Syrup & Suspension)
- Soft Gelatin Capsules
- Dry powder for Oral Suspension
- Suppositories and Ovules
- Topicals (Creams, Lotions & Ointments)
Location : Suthukeny, Puducherry
CSL (CP-IV)
Caplin Steriles Limited, (CP-IV) is a US FDA, EU-GMP, INVIMA and WHO-GMP approved manufacturing facility handling Sterile Injectable and Ophthalmic dosages.
The Site has a dedicated facility for formulation development, analytical development and stability department for product development in sterile dosage forms.
Plant capacity is:
- Liquid & Lyophilized Vials :140 Million per annum
- Pre-Filled Syringes :16 million per annum
- 3-pc Ophthalmic Droppers :7 million per annum
- Pre-Mix Bags :4 million per annum
Location : Gummidipoondi, Chennai
For more information on Caplin Steriles, please visit www.caplinsteriles.net
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.
CP-104 TICEL Bio-Park
A dedicated R&D facility to develop dosage forms like Immediate Release Tablets, Extended Release tablets, Capsules, Semi-solids (including suppositories), Liquid orals, Granules, Soft Gelatin Capsules and Multi-particulate systems (MUPS).
Some of the studies performed by separate teams of Formulation and Analytical R&D scientists at this unit are listed below:
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Design and development of new dosage forms as per market requirements.
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Formulation development approach with QBD concepts using DOE.
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Design and development of Bioequivalent dosage forms for various markets.
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Analytical method development and Method validations as per ICH guidelines.
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Conducting Stability studies as per ICH guidelines.
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Technology transfer of new developed formulations to production locations.
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Process optimization and process improvement of commercial products.
The unit is approved by Department of Scientific and Industrial Research (DSIR), Government of India.
Location : Module No 307 & 308, Phase-II, 3rd Floor,
TICEL Bio Park Limited, No. 05, CSIR Road, Taramani,
Chennai-600113.
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
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
For more information on Amaris Clinical, please visit www.amarisclinical.com
Targeting for following approvals
R&D Capabilities: CP-V (Perungudi)
A dedicated R&D facility developing a wide range of products covering Injectables – Liquid Injectables in Vial and PFS presentations, Ophthalmic products and Lyophilized products. Development is specifically focused towards regulated markets of USA, Europe among others.
A strong team of scientists work on areas related to Formulation Development, Analytical Development, Technology Transfer, Quality Assurance, Strategic Sourcing, Dossier Preparation and Regulatory Filings.
Outsourced Manufacturing
In addition to own manufacturing, Caplin develops and transfers product technology to approved manufacturing sites, as part of its Outsourced Manufacturing initiative for products where in-house manufacturing is unavailable/restricted. Some of these sites are also approved by US FDA, WHO-GMP and ANVISA.
International Presence
China Outsourced Manufacturing
Caplin Point has forged long term exclusive partnerships with leading companies from China for manufacturing of formulations and medical disposables. A stringent Vendor Qualification and Audit process is completed prior to the approval for manufacturing. Further, every batch of product manufactured is once again tested at Caplin’s own Quality Control lab in China, prior to release.
Location: Shijiazhuang, China.
Caplin Point Far East Ltd (HK)
This wholly-owned subsidiary of Caplin Point engages with outsourcing of Pharmaceutical and Nutraceutical formulations from China and surrounding regions.
Latin American Subsidiaries:
| Country | No of Products Registered | No of Employees |
|
Guatemala
|
611
|
147
|
|
Nicaragua
|
419
|
75
|
|
Honduras
|
435
|
49
|
|
El Salvador
|
362
|
30
|
|
Ecuador
|
230
|
41
|
|
Colombia
|
7 | 1 |