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Intermediates and API Contract Manufacturing Services Intermediates and API Contract Manufacturing Services

Intermediates and API Contract Manufacturing Services

Long-term partner to support your commercial product through its market lifecycle.

Aurigene has a legacy of developing 500+ molecules, several of which are in the commercial phase in highly regulated markets such as the USA, Europe, Japan, etc. We support our customers at various stages of a late-phase product from regulatory filing to launch and at the patent expiry stage with cost optimization options. Our vast manufacturing footprint allows us the flexibility to choose from a variety of unit operations suitable for product manufacturing. Our expertise in regulatory filings and documents will help our customers create comprehensive documentation for NDA and other global regulatory filings.    

We offer a wide range of manufacturing services from a few kilos to multi tons of cGMP manufacturing of Key Starting Material (KSM) / Registered Starting Materials (RSM), advanced intermediates, and APIs. Our facilities can handle a diverse set of chemical reactions at various scales. Our facilities are inspected by global regulatory authorities like the US FDA, UK MHRA, TGA Australia, PMDA Japan, and other regulatory agencies. Our facilities can handle the manufacturing of niche technologies like peptides, High Potent Active Pharmaceutical Ingredients (HPAPIs), steroids, Methoxy Polyethylene Glycols (m-PEGs), and prostaglandins. Our state-of-the-art facilities are located across the globe in India, the UK, and Mexico.

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cGMP Manufacturing Scale

Reactor size

  • Kilo lab: 50 to 630 L
  • Commercial: 500 to 10,000 L

Capacity of Production

  • Kilo lab: 1 to 10 Kg
  • Commercial: 15 to 500 Kg


  • All glass set-up, Mild Steel Glass Lined (MSGL), stainless steel (SS316), and Hastelloy

Niche reactions

  • Cryogenic reactor size (2,000 to 11,000 L) with Reaction temperature up to -80 deg C
  • Hydrogenator capacity (20 to 5000 L) at 4 to 3535 bars

Downstream Operations


  • 12”, 36” and 48”

Nustche Filters

  • 25 L to 1 KL

Agitated Nustche Filter Dryer (ANFD)

  • 0.1 m2 to 5.0 m2

Spray Dryers

  • 5 to 50 Kg/Hr


  • Development (M50)
  • Manufacturing (M100 to M2000

All manufacturing facilities are equipped with particle size regulating equipment including multi-mill, air jet mill or micronizer, sifter, and blenders. Dedicated unit for the micronization of steroid products. Steroid manufacturing facility is also equipped with micronizer.



  • Quantity: 10 to 50 g
  • Capacity: Lab scale

Pre-clinical or Non GMP

  • Quantity: 100 to 250 g
  • Capacity: 20 to 50 L

Early Phase

  • Quantity: 1 to 3 kg
  • Capacity: 20 to 189 L

Late Phase

  • Quantity: 5 to 10 Kg
  • Capacity: Up to 7,000 L


  • Quantity: 25 to 100 Kg
  • Capacity: Up to 7,000 L


Development/PoC/Non GMP

  • Quantity: 10 to 50 g
  • Capacity: Lab scale


  • Quantity: 100 to 250 g
  • Capacity: Lab scale

Early Phase

  • Quantity: 1 to 3 kg
  • Capacity: ~20 to 2,000 L

Late Phase

  • Quantity: 5 to 10 Kg
  • Capacity: 160 to 2,000 L


  • Quantity: 10 to 15 Kg
  • Capacity: 160 to 2,000 L



  • Quantity: 10 to 50 g
  • Capacity: Lab scale


  • Quantity: 250 to 500 g
  • Capacity: Lab scale

Early Phase

  • Quantity: 25 to 50 kg
  • Capacity: 50 to 3,000 L

Late Phase

  • Quantity: 100 to 250 Kg
  • Capacity: 50 to 3,000 L


  • Quantity: 500 to 1,000 Kg
  • Capacity: 50 to 3,000 L



  • Quantity: Up to 100 g/batch
  • Capacity: Lab scale


  • Quantity: Up to ~30 Kg/batch
  • Capacity: 60 to 250 L

Purification: GPC technique, size-exclusion chromatography, SAX purification, Ion-exchange chromatography

Analytical Capability at The Plant


  • HPLC (UV, PDA, ELSD & RI detectors with Empower 3 software)
  • GC (FID, TCD, ECD detectors with Empower 3 software)
  • UPLC instruments


  • Mass spectrometer (LC-MS & HR-MS)
  • AB SCIEX 4500 QQQ instrument
  • Waters UPLC with LCT premier XE time of flight detector
  • Agilent HPLC with 6410 triple quad mass detector
  • Agilent GC with 5975C EI/CI Inert XL detector

Spectroscopy and Thermal analysis

  • UV-Vis, IR, NMR spectroscopy, and photometers
  • DSC and TGA
  • Surface area analyzers

Sustainable Manufacturing

Sustainability is one of our core values and we continue to build on our goals aligned with global standards. Our work in the field of sustainability was recognized by:

  • DJSI (Dow Jones Sustainability Indices)
  • FTSE4Good Index
  • CDP (Carbon Disclosure Project)
  • S&P BSE Carbonex
  • S&P BSE Greenex
  • Bloomberg Gender-Equality Index
  • CII-SR EHS Excellence Silver Award
  • PSCI Audited


Our development center is a US FDA audited facility, and our manufacturing plants are regularly audited by the US FDA, EDQM, KFDA (Korea), MHRA (UK), PMDA, SFDA, CDSCO, DMA, TGA, WHO GMP, and COFEPRIS.

Why Aurigene Pharmaceutical Services?

US FDA Inspected Labs

Integrated Development and Manufacturing

25 to 50 gms per batch

Dedicated Analytical Lab

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