Rubicon commissioned its cGMP facility at Ambernath (Thane) in October 2010. This 65,000 sq.ft state-of-art plant embodies the vision and exactitude that Rubicon has exemplified over the years. This meticulously designed plant is compliant with USFDA and EU specifications with 20,000 sq.ft. of the entire area is specially devoted to cGMP manufacturing of Class 100,000.
It is a multi-product manufacturing facility, designed for use for the pharmaceutical manufacture of oral solid dosage forms catering to the international markets including the United States and the European Union.
The facility is designed to develop and manufacture Oral Solid Dosage Forms such as
- Immediate Release Tablets (Coated and Uncoated)
- Dispersible tablets
- Orally disintegrating tablets
- Controlled / Modified release tablets and
- Hard Gelatin Capsules
Rubicon has been audited by the following Regulatory Bodies
- German Health Authority: Audited and approved by ‘Freie und Hansestadt’ Hamburg” for Stability and Analytical services. Certification is valid for 27 European countries
- UK MHRA: Approved
- US FDA: Approved
- TGA Australia: Approved with mutual recognition with MHRA
Capacity of Manufacturing for Oral Solids
|Compression tabs ( 400mg)||1224 million units|
|Coating 400 mg||600 million units|
|Blister packing||576 million units|
|Capsule filling||132 million units|
|Bottle packing||600 million bottles|
The core manufacturing area is planned in a modular fashion and can be extended to add additional capacity as per requirements
GMP R&D Laboratory
We have a GMP formulation and analytical development center in the plant premises which is ear marked for R & D activities and we develop the following dosage forms in the facility
- Oral Liquid Dosage Forms
Clear Liquids, Syrups Suspensions, emulsions etc.
Ointment and Creams, Lotion etc.
Equipment List available on request