We have a well-established formulation development lab to carry out formulation development activities of Oral solid and Parenteral dosage forms in our state-of-the-art R and D facility located in Hyderabad. This R and D center is dedicated to custom development projects. We are capable to handle small quantity batch size as low as 50g blend. This enables to reduce the API requirement for formulation development significantly.
Our R and D facility was audited by the US FDA in September 2017 and is also ISMS certified. All activities around formulation development including process optimization are carried out in this facility.
Our parenteral formulation development lab includes equipment such as Martin Christ 2-10D LSC plus pilot scale lyophilizer with a 10 liters condenser capacity, Fedegari counter pressure autoclave with 90 liters capacity and Memmert hot air oven. We are also equipped with IKA Ultraturrax’s T25 high shear mixer, Masterflex dosing pump and Laminar air flow system. The facility includes jacketed manufacturing vessels with one, two and five liters capacity, head space oxygen analyser, freezing point depression osmometer, conductivity meter, pH meter and Dissolved Oxygen meter. Validated stability chambers for conducting accelerated and prototype stability tests that support the selection of a lead and back-up formulation.
We have state-of-the-art US FDA and EU-approved pilot and production manufacturing facilities for scale-up where we offer clinical and commercial batches. The capacity varies from 15 - 1000 kg in the case of solid orals. The offerings include tablets, capsules and powder in sachets and soft gelatin capsules.
SEPTEMBER 04, 2023
Discover the Opportunities: Visit Aurigene Pharmaceutical Services at CPHI BarcelonaThe Contract Research, Development and Manufacturing Organization (CRDMO) industry is a dynamic and rapidly evolving sector emerging as it plays a vital role in providing a wide range of services enabling drug companies to bring their products to market efficiently and effectively...
Read MorePersonalized 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 in enabli...
Read MoreObjective & Challenges: Objective was to identify an optimized anti-bacterial lead molecule with in vivo efficacy in relevant infection models an acceptable safety profile, and a patentable series. Challenge was to develop a more efficacious compound than the reference standard.Study design: Compounds were designed and synth...
Read More2023
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 More2005
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 More2005
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 More2005
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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