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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Learning Resources
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Project Requirement:Cyclic peptides were to be analyzed for Kinetic solubility, Chrom Log D, MDCK, PAMPA, & Caco2 experiments, while overcoming the challenges associated with the impact of cyclization of peptides on in vitro experiments and bioanalysisWhat were the challenges!1. Nonspecific Binding (NSB)2. Precipitation of peptides while spiking DMSO stock to...
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Proteolysis-targeting chimera (PROTACs) represents a promising modality that has gained significant attention for cancer treatment. Using PROTAC technology, we synthesized novel structurally modified paullone-based PROTACs using Cereblon (CRBN) and Von Hippel–Lindau (VHL) E3 ligands....
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Development and verification of RP-HPLC method for the quantitative determination of Decitabine in tablet dosage formulation
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Decitabine is an anti-cancer chemotherapy drug. This article describes method development and method verification of Assay of Decitabine in tablet formulation. A new, precise, rapid, accurate RP-HPLC method has been developed for the estimation of Decitabine in pharmaceutical tablets dosage form. After optimization the good chromatographic separation was achieved...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
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Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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Dr. Reddy’s Laboratories, Aurigene Pharmaceutical Services, and Kainomyx announce potential partnership for joint development of affordable anti-malarial drug
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Aurigene Pharmaceutical Services Limited, a global CRDMO, and Edity announce a strategic collaboration in cell therapy
2024
Aurigene Pharmaceutical Services Limited (Aurigene), a global contract research, development, and manufacturing services organization (CRDMO), will provide discovery services to Edity Therapeutics Limited (Edity) in cell therapy. Dr. Reddy’s Laboratories Limited, Aurigene’s parent company, recently made a strategic investment in Edity, a biotechnology company...
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Aurigene Pharmaceutical Services Limited, a global CRDMO, announces the opening of its biologics facility offering process development and clinical scale manufacturing capabilities
2024
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Aurigene Pharmaceutical Services Ltd., and Vipergen announce a strategic partnership for offering DNA encoded library (DEL) screening and integrated drug discovery services
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