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| Focus Areas - Research & Development |
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Formulation & Development Department:
Aanjaneya Formulation and Development section is well equipped with lab-scale equipments to enable proper Formulation & Development of tablets, liquids, and topical formulations. |
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Analytical Method Development Department:
The Analytical Method Development department supports all the developmental work providing support for Active Pharmaceutical Ingredients and Formulation and Development.
The department is equipped with the most modern sophisticated instruments.
Walk in stability chambers having capacity of 8000 liters and with data logger software
new analytical method development by HPLC for APIs and dosage forms is with respect to
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Stability indicating methods for assay |
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Impurity profile |
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Dissolution |
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Residual solvents and organic volatile impurities by Gas Chromatograph |
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This analytical method development will have a team of 10 qualified and experienced scientists.
The department is well equipped with highly sophisticated instruments like High Performance Liquid Chromatography, Gas Chromatography, Differential scanning calorimeter, UV spectrophotometers, infra red spectrophotometer, walk-in stability chambers and dissolution apparatus.
Method validation and stability studies are carried out as per ICH guidelines.
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Active Pharmaceutical Ingredient Department:
The API process development lab at MAanjaneya is equipped with capabilities to handle multi-step chemical synthesis involving reaction types like, Catalytic Hydrogenation & Hydride Reductions, Heterocycle & Aminoacid Synthesis, and Optical Resolution & Reactions involving the use of Chiral Substrates.
The well-equipped Lab. at the R & D Centre strives to develop competitive and cost effective commercial processes for the production of APIs. Aanjaneya Lifecare is among the first pharmaceutical company in the country to have improvised the existing route of synthesis for
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Quinidine Sulphate |
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Quinine Ethyl carbonate |
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Docetaxel Anhydrous |
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Bioequivalence study Centre:
In order to conduct bio-equivalence studies to assure high level of confidence and meet with time-lines Aanjaneya has tied up with Roxaane Research Centre at Chennai India.. It strives to ensure high quality clinical, bio-analytical, statistical and pharmacokinetic data necessary to create international harmonization in bioequivalence testing. The harmonization in the requirements and standards for bioequivalence testing would be achieved by conducting all the studies as per the GCP and GLP regulations and other regulatory guidelines.
The center has 100 bed facilities with in house well equipped Emergency care unit, well developed bio-analytical section with state of art equipments such as LC /MS MS, HPLC, Low Temperature Freezers and Centrifuges. The facility is well enabled with IT systems such as SAS version 9.1 for statistical computation, bio-enable software for volunteer registration and access control system for prevention of unauthorized movement of personnel.
The bio-equivalence study center operates as per the well-established quality system supported by set of written standard operating procedures pertaining to specific activities and equipments in the facility. The center will be conducting activities such as :
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Bioanalyticatical method development and validation |
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Pilot BA/BE Studies |
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Pivotal BA/BE studies |
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Pharmacokinetics study in special population |
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Multiple dose effect study |
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Food effect study |
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IVIVC (In-vitro In-vivo co-relation) |
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