We offer highly potent small molecule development services for API and intermediates, operating from our development facility in Hyderabad, India. The development lab can handle molecules with OEL 0.1 µg/m3. We have a systematic approach to managing High potent APIs. which makes us one of the safest partners of choice for all your discovery needs.
We can handle various potent molecules viz., heterocyclic, nucleosides, steroids and carbohydrates.
Our approach for HPAPI handling 
Key highlights of our services include
Dedicated HPAPI labs
- Self-equipped high potent chemical development lab with fume hoods (with negative pressure), barrier isolation, balance connected with isolator
- Multi-purpose solids handling suites
- High potent analytical labs with dedicated equipment connected with pass box
- Biometric access control system
- Capable to take up the development of HPAPI/Intermediates with OEL of 0.1µg/m³
- Man-material entry and exit are separated to avoid contamination
- Mist shower facility available for exit
Dedicated high potent analytical lab
- HPLC instrument with UV, DAD and CAD detectors
- Gas chromatography with ALS and headspace injectors
- Analytical balance (placed in Xpert filtered balance system)
- pH meter
- Ultrasound sonicator and rotary shaker
- Zeta sizer
- Isolator with HEPA cartridge for closed handling of the HPAI compounds
- Pass box for sample transfer and atmos bag
- Fume hood chemical handling and mobile phase preparations
Why Aurigene High Potent API Development and Manufacturing Services?
Integrated development and manufacturing
Dedicated analytical lab
Well-experienced team
Legacy of having developed and manufactured complex high potent products
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Resources
FEBRUARY 25, 2025
Transforming Drug Discovery with Aurigene.AI
In the early 2000s, developing Sovaldi, a hepatitis C treatment, took over a decade and nearly $2 billion. Similarly, Zolgensma, a gene therapy for spinal muscular atrophy, required 15 years due to its complexity. However, the advent of artificial intelligence (AI) has revolutionized drug discovery. For example, in 2022, Pfizer's PAXLOVID, an oral COVID...
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Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role...
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Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
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Familiarization, process optimization, and cGMP manufacturing and supply of 30.0 kg of a Bioactive Nucleotide (NAD Booster)
Background: A US-based biopharmaceutical company approached Aurigene Pharmaceutical Services for the familiarization, process development, and cGMP manufacturing and supply of 30.0 kg Nucleotide product (NAD booster) for phase-appropriate studies. The synthesis of the desired product involves three linear stages, which starts with reaction of a pentose...
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Identification of Degradants of Thermal and Oxidation Stress Studies of Empagliflozin and Linagliptin Tablets by HPLC-PDA and LC-MS Instrumental Techniques
2022
Objective of the manuscript is to identify the degradants observed in the thermal and oxidation degradation sample of Empagliflozin and Linagliptin tablets by using LC-MS and HPLC-PDA instrumental techniques. Thermal and oxidation degradation samples were injected in HPLC-PDA and LC-MS instruments. Mass of the degradants were detected by LC-MS technique, ...
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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
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Wang-OSO3H catalyzed green synthesis of bioactive isoindolo[2,1- a ]quinazoline-5,11–dione derivatives: An unexpected observation
2005
The sulphonic acid-functionalized Wang resin (Wang-OSO3H) was explored as a polymeric and recov- erable acidic catalyst for the synthesis of isoindolo[2,1- a ]quinazoline-5,11–dione derivatives under green conditions. Thus the Wang-OSO3H ...
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Polycyclic Aromatic Compounds: A Simple and Efficient [(n-Bu3Sn)2MO4]n Catalyzed Synthesis of Quinazolinones and Dihydroquinazolinones
2005
A novel unprecedented approach for the synthesis of various quinazolinones and dihydroquinazolinones has been using [(n-Bu3Sn)2MO4]n as a catalyst. The reaction has been screened ...
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