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.
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
MOC
- 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
Centrifuge
- 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
Micronization
- 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.
Steroid
Development/PoC
- 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
Commercial
- Quantity: 25 to 100 Kg
- Capacity: Up to 7,000 L
HPAPI
Development/PoC/Non GMP
- Quantity: 10 to 50 g
- Capacity: Lab scale
Pre-clinical
- 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
Commercial
- Quantity: 10 to 15 Kg
- Capacity: 160 to 2,000 L
PEGylation
Development/PoC
- Quantity: 10 to 50 g
- Capacity: Lab scale
Pre-clinical/NGMP
- 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
Commercial
- Quantity: 500 to 1,000 Kg
- Capacity: 50 to 3,000 L
Carbohydrate
Development/PoC
- Quantity: Up to 100 g/batch
- Capacity: Lab scale
Commercial
- 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
Chromatography
- HPLC (UV, PDA, ELSD & RI detectors with Empower 3 software)
- GC (FID, TCD, ECD detectors with Empower 3 software)
- UPLC instruments
Characterization
- 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
Regulatory
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
Other Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Pharmaceutical Analytical Services
Polymorph Screening
ADME/DMPK Services
Drug Formulation Services
In vivo Pharmacology
Medicinal Chemistry
Microbiology Testing
Peptide Synthesis
Development and Kilo Lab
Toxicology Studies
Resources
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Evolution in Pharma Industry and Demand for Integrated CDMO
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Developing a methodology for In situ perfusion based combined tissue distribution and toxicity evaluation study
Challenges: Several repeated in house validation studies were performed to optimize the suitable perfusate (liquid medium intended to pass through the heart), perfusate volume and perfusion rate to ensure complete perfusion of animal subjects (parameters weren’t adjustable) Challenges were encountered in adjusting the perfusion volume and rate vis-à-vis ensuri...
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Revisiting the reaction of b-chloroacroleins with 2-aminophenol: a new observation
2008
The reaction of b-chloroacrolein with 1 equiv of 2-aminophenol in DMF proceeds smoothly to afford 11-hydroxy derivative of chromenoquinoline in good yield. This single pot method allows for a rapid access to a variety of chromenoquinolines or oxepinoquinolines depending on the nature of b-chloroacrolein used. The structures were established by spectroscopic data ...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2005
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in tablets
2005
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E) 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
2005
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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