At Aurigene, we have a well-experienced team that is skilled with global quality and regulatory guidelines to complement your projects with the right set of small molecules development activities. We have a state-of-the-art analytical lab through which we can develop a variety of analytical methods. We offer comprehensive process development solutions to identify and develop the most optimal process for your compounds including New Chemical Entity (NCE), advanced intermediates and Key Starting Materials (KSM).
We provide small molecules development services from our R and D center in Hyderabad. This facility handles process development and non-GMP supplies at a 0.5-kilogram to 2-kilogram scale and enables the tech transfer to GMP facilities for clinical supplies. This facility is equipped with 15 chemistry labs and an analytical center of excellence that is fully equipped for chromatography, characterization, spectroscopy and thermal analysis.
Our R and D center houses a dedicated high potent lab. The peptide labs are housed with manual and automatic synthesizers that can handle solid, liquid, and hybrid synthesis. The high potent lab can handle products with OEL <0.1 µg/m³. In addition, we operate 3 non-GMP kilo labs including a steroid line.
We also have labs that carry process safety and powder safety studies. Our crystallization and risk assessment lab carries out a comprehensive solid-form screening, crystallization, and development of API to meet the desired specifications including solvent screening, polymorph screening, solubility studies, crystallization studies, PAT studies, scale-up studies and particle size distribution.
Clinical and commercial supplies are enabled through our eight US FDA-inspected GMP facilities across India, UK and Mexico. The sites can handle various technology platforms and have a variety of unit operations to suit our customer’s unique development needs.
Other Services
- Analytical Development and Validation Development Services
- Crystallization and Polymorphism Development Services
- Drug Discovery Services
- Non-GMP Pilot Development Facility
- Process and Powder Safety Assessment
Analytical Development and Validation Development Services
Crystallization and Polymorphism Development Services
Drug Discovery Services
Non-GMP Pilot Development Facility
Process and Powder Safety Assessment
Process Development and Validation Development Services
Small Molecules Manufacturing Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Polymorph Screening
Resources
APRIL 24, 2023
The importance of business continuity planning in CRDMO industry
Both natural and unnatural catastrophic events inflict negative consequences due to the ever-increasing interconnectedness of the global economy. Those consequences are certain to last for longer duration. e.g.; The Covid-19 pandemic is still having a negative impact on the global economy. Maintaining continuity is critical for all businesses, but perhaps no othe...
Read More
Evolution in Pharma Industry and Demand for Integrated CDMO
The pharma industry is evolving and a demand for integrated CDMOs, which can help accelerating innovations, is part of the evolution....
Read More
Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
Read More
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 ...
Read More
A cascade reaction for the new and direct synthesis of indolofuroquinoxalines
2016
The 7H-indolo[30 ,20 :4,5]furo[2,3-b]quinoxaline derivatives are synthesized directly from methyl 2-(2- chloro-1H-indol-3-yl)-2-oxoacetate or its N-alkyl derivatives under neutral or mildly acidic conditions. This new one-pot methodology was found to be general and greener as it avoids the use of environmentally harmful POCl3 and strong alkali required for the pr...
Read More-
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 ...
Read More -
A Sensitive and a Simple RP-HPLC Method Development and Verification for the Quantitative Estimation of Cholecalciferolin 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 formul...
Read More -
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 ...
Read More
You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.
If you wish to continue to this external website, click Proceed.
Leaving already?
Don't forget to join us at
CPHI Worldwide 2023.
October 24th-26th, 2023 | Barcelona, Spain
Get ready to accelerate your drug’s journey to the market