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.
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Resources
OCTOBER 01, 2024
PROTACs: Research for a life without cancer
PROTACs: Proteolysis-targeting chimeras (PROTACs) are a rapidly evolving field with promising applications in cancer, neurodegenerative diseases, and other conditions where the regulation of protein levels is crucial. PROTACs are a novel class of small molecules designed to target specific proteins for degradation by the ubiquitin-proteasome sys...
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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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Case study: Tackling CYP 2C9 inhibition challenges
The Problem: Active compounds in a project were found to be highly potent inhibitors of CYP 2C9 The compounds selectively inhibited CYP 2C9 with IC50 values <100 nM There was no considerable inhibition of the other CYP isoforms Our Mitigation Approach: CYP 2C9 inhibition data was generated for a larger set of co...
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Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2022
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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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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