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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.