Synthesis

BUSINESS UNITS / Synthesis

We offer cutting-edge synthesis services trusted by leading research labs and
companies worldwide.

Dr Ravi Kumar is a Executive Director of our company for South Korea, China & Japan operations. He published more than 100 research articles, 10 book chapters, and 6 patents in the area's Pharmaceuticals, Multi-step organic Synthesis, Nanoparticles, Materials Chemistry, DNA & RNA Chips, Biomimetics, TENGs, Graphenes & Metal oxide Promoters. Also, Dr Ravi Kumar is a peer reviewer for International academic & Industrial Journals, and he has attended diversified International conferences around the Globe.

Innovative, robust and scalable chemistry is the core strength of Indivar. We support drug development and manufacturing programs for global pharmaceutical and biotech companies at all stages from pre-clinical stage to commercialization. Our development and manufacturing teams maintain a tight focus on performance at scale, continuous process improvement, securing and de-risking supply chains to provide an efficient, compliant, cost-effective and long-term commercial drug substance and drug product solutions. .

Indivar is well-positioned to meet all NCE Drug Substance and Drug Product needs of clients, from preclinical through commercial manufacturing. The strong analytical chemistry team at Indivar works with the chemical development and tech-transfer teams to provide necessary phase-appropriate support to clients for their drug substance and drug product analytical development needs. The drug product development team at Indivar is well-equipped to develop all types of formulations both for NCEs, Generics and other specialty products. Our comprehensive analytical infrastructure complements this capability.

Indivar established a leadership position for itself in the manufacture and supply of nature identical and highly-pure polyphenols (Curcumin, Resveratrol, and Pterostilbene etc.). We developed technologies for several key ingredients including carotenoids (Betacarotene, Astaxanthin), Huperzine A and novel nutraceutical co-crystals of Pterostilbene, Caffeine and Curcumin with enhanced bioavailability and controlled absorption properties.

Indivar also manufactures safe and effective natural ingredients for weight management, sports nutrition, joint health, metabolic disorders, eye health, skin care, and general wellbeing. Our Ingredients division also offers Contract Development and Manufacturing services for Nutraceutical clientele through manufacturing procedures that conform to the international compliance standards prescribed by GMP, Kosher, Halal and HACCP etc. With manufacturing efficiency and quality rigor that match those of our pharmaceutical APIs, our Ingredients have gained a reputation for consistent quality and supply assurance.

A. Contract Development

Drug Substance Services
  • Chemical process development (Pre-clinical to P-III/Commercial
  • Drug substance manufacture, including HPAPIs
  • CMC and regulatory filings support
  • Custom synthesis
  • Analytical Development Services
  • Method development
  • Method validation
  • Stability studies
  • Impurity identification, characterization
  • Reference
  • Product Development Services
  • Pre-formulation studies
  • Dosage form development for NCEs
  • Formulation
  • B. Contract Manufacturing

    APIs, Finished Dosage Forms & Starting Material
    • Tech-transfer from client sites with project management support
    • Securing RM supply chain by continuing existing sources and identifying new cost-effective sources; back-integrating the manufacture wherever necessary
    • Custom build and dedicate equipment trains, blocks and manufacturing facilities, wherever necessary

    C. Niche Solutions

      HP API
    • Extensive experience in handling manufacture of Highly-Potent (Cytotoxic and Steroidal Hormones) APIs & Intermediates both at Pilot scale & commercial scale ; Dedicated cGMP Containment manufacture capability at all scales and across multiple sites.
    • Facilities designed for enabling operational containment levels of OEL
      Collaborative and Integrated Offerings
    • Integrated Drug Substance and Drug Product Development
    • Dedicated facility deployment and manufacture

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