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.
- Synthesis of impurities.
- Library of impurities is now available.
- Development of non-infringing and stable polymorphs.
- Desired particle size and particle geometry.
- 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.
- Skills in high temperature and pressure, cryogenic and organometallic reactions.
- Chiral synthesis.
- Oncology products.
- Potent compounds.
- Sterile injectables in pre filled syringes and pen devices.
- Oral solids and sachet.
- Sterile ophthalmic & otic dosage forms.
- 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.