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 
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 Pharmaceutical Services?
Integrated development and manufacturing
Dedicated analytical lab
Well-experienced team
Legacy of having developed and manufactured complex high potent products
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Hyderabad R and D Center
Bangalore R and D Center
Resources
JANUARY 04, 2021
Application and Manufacturing of High Potent Active Pharmaceutical Ingredient (HPAPI)
High Potent Active Pharmaceutical Ingredient (HPAPIs) are majorly used to treat oncology-related conditions. Usually, a compound is considered high-potent when the operational exposure limit is below 10 µg/m3 of air as an 8-hour time-weighted average. High Potent drugs can be administrated through oral, injection or topical route depending on the source of the d...
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HPAPI Development at a Glance
The pharmaceutical industry's journey to improve patients' health has enhanced the number of more effective HPAPIs (High Potent Active Pharmaceutical Ingredient) in development pipelines. Traditionally, HPAPIs were exclusively concomitant with oncology therapeutics. ...
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High Potent API (HPAPI) Manufacturing Services
Aurigene Pharmaceutical Services has experience, expertise and infrastructure to develop and manufacture oncology drug candidates including HPAPI ...
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Delivering 3 g dose of emetic and poorly bioavailable compound for 90 days repeated dose toxicity studies in dog
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...
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Construction of a quinoline ring via a 3-component reaction in water: crystal structure analysis and H-bonding patterns of a 2-aryl quinoline
2012
Montmorillonite K-10 mediated green and one-pot synthesis of 2-substituted quinolines has been accomplished via a 3-component reaction of aniline, aldehydes and ethyl 3,3- diethoxypropionate in the presence of air oxygen in water. The crystal structure analysis and H-bonding patterns of one compound prepared are presented. ...
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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2005
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...
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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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Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2005
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...
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