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Custom Synthesis and 

Contract Manufacturing


Contact us for the following services:

Custom Synthesis and Contract Manufacturing

Scale up from milligrams to 50 kg in pilot plant and up to multi ton for commercial production under cGMP in FDA approved facility.

Supply of NCE's for preclinical and clinical studies.

USFDA, MHRA, AFSAPS/EMEA approved manufacturing locations.

 

Pharmaceutical Impurities

Synthesis of impurities.

Library of impurities is now available.

 

Polymorph Development

Development of non-infringing and stable polymorphs.

Desired particle size and particle geometry.

 

Custom Formulations

Development, scale up and technology transfer of all dosage forms.

Quick development of immediate release solid and liquid orals.

Development of controlled release, sustained release, modified release and timed release products.

Development and commercialization of differentiated dosage forms such as orally disintegrating tablets, effervescent tablets, chewable tablets.

Development of bi-layer, multi-layer, tablet in tablet technologies.

Particle / bead coating and bead manufacturing using extruder and spheronizer technologies.

 

Niche Capabilities

Skills in high temperature and pressure, cryogenic and organometallic reactions.

Chiral synthesis.

Oncology products.

Peptides.

Cephalosporins.

Potent compounds.

Sterile injectables in pre filled syringes and pen devices.

Oral solids and sachet.

Sterile ophthalmic & otic dosage forms.

 

Bioequivalence Studies

DCGI, USFDA, MHRA approved bioequivalence faciltiy.

Data storage and archival facility.

6500+ volunteer database.

Full bioanalytical department with HPLC, LC-MS/MS and GC.

 

All work is performed under strict confidentiality.



 

 



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Last modified: December 1, 2009