Non-GMP and GMP Manufacturing

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Non-GMP and GMP Manufacturing

With full integrated cGMP facilities, our small to large scale manufacturing capacities and technologies provide reliable outsourcing services our clients need, spanning complete supply chain from early clinical-phase development to commercialization.

Jubilant Biosys brings decades of API development and manufacturing experience to deliver high quality drug substance.

Our flexibility allows us to manufacture from a lab scale of just a few grams to kilograms in our GMP pilot plant or to industrial quantities. Compliance with the highest cGMP standards is always assured for a qualified contract development and manufacturing process.

As your CDMO partner, we deliver tailored end-to-end solutions spanning your supply chain at all stages, from drug development to commercialization.

Our understanding of the development process, and access to resources ensures fast and reliable supply of APIs. We provide seamless technology transfer from the research labs to cGMP manufacturing facilities.

  • Key Raw Materials
  • GMP Starting Materials
  • Non-GMP Intermediates
  • Intermediates & APIs

Kilo Lab for GMP scale up is now operational at our API manufacturing site

Capability

Equipment

  • 10L, 30 L Hastelloy reactors.
  • Independent Temperature Control Unit.
  • 10 L All Glass Reactors.
  • Nutsche filter (5L) and VTD (2 tray).

Scale-up at Delhi sites up to 20 kg 

Scale up
  • 40 Clients catered in past 3 years.
  • 153 Projects completed in past 3 years.
  • 10 Scale up NCE (Up to 20kg).
Key Activities
  • Route scouting, process design and optimization.
  • Development and standardization of synthetic steps considering scalable manufacturing needs.
  • Synthetic demonstration scale-up manufacturing.
  • Analytical method development & stability studies.
  • Salt screening and polymorph studies. Transfer of process technology to pilot plant for advanced molecules.
  • Well-established kilo laboratory for the synthesis of compounds in multi-grams to kilograms level.
Equipment
  • Scale-up hoods to accommodate multiple 20L reactors.
  • 20L jacketed reactors with TCU.
  • 250 L SS reactor with independent TCU.
  • 100 L Double-jacketed Glass reactor and 130 L Hastelloy reactor with independent TCUs.
  • Multiple centrifuges, Multiple Nutsche filter.
  • Column area for 3 jumbo columns, Multiple Rotavap of 20L and 50L.
  • Multi-mill, Jet-mill & Sifters

GMP Scale up at our pilot plant in Nanjangud for scale up to 20 kg

  • ~30 Clients catered in past 3 years.
Key Activities
  • Different variety of reaction vessels including a coil reactor for continuous reactions.
  • Distillation: Batch distillation, Atmospheric, Azeotropic high vacuum distillation.
  • Filtration: Centrifuge/Nutsche Filter/Pressure Nutsche filter/ Agitated Nutsche filter & dryer.
  • Drying: Vacuum Tray Dryer/ Agitated Nutsche filter & dryer/RCVD/FBD.
  • Milling & Size reduction: Air Jet Mill/Multi mill/Sifter Absorption: Scrubber for hazardous fumes.
  • Hydrogenation: Separate area for hydrogenation Lyophilizer and Rotavaps for specific product requirements.
Equipment
  • Capacity: 4.3KL (~250 kg/month).
  • cGMP Plant 23 Reactor system.
  • 8 Glass line reactors, 4 Hastelloy reactor, 13 SS reactors.
  • 2 Streams of clean rooms 250L SS Hydrogenator @ 10kg/cm2.
  • 20L Rotavapour, 20L Lyophilizer.
  • 200ml Coil reactor for continuous flow reaction, 100L SS316L Reactor for cryo reaction (- 150° C).

*Belongs to the parent company, Jubilant Pharmova Limited.

You can rely on Jubilant Biosys for high-quality API development and API manufacturing services, supporting programs from early pre-clinical and clinical phases through commercial supply.

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