PROFILE
The company's R&D strengths are in creating intellectual property assets by developing non-infringing, novel, cost effective and environmentally friendly processes for Formulations and finding easier solutions to complex chemistry challenges. We are specialized in constructing chiral molecules with strong expertise and experience in the resolution processes. Our R&D team consists of more than 60 qualified scientists with extensive expertise and experience in Process Research and Development activities for Formulations and their critical intermediates. Our main philosophy is backward integration of Formulations synthesis starting from basic raw material, thereby being self-dependent for critical intermediates to control cost and quality. Solid state studies, particularly polymorphism and particle size are proving to be bottle neck in marketing newer Formulations. At Mickle, scientists are skilled in providing solutions to the problems associated with them. We have two research centres, one at Baddi, Himachal Pradesh, India and another at Nangal, Punjab, India. R&D centre at Baddi is mainly focused to provide critical intermediates with high purity and low cost through intensive research to our main R&D centre at Baddi and as well as to our partners around the globe. A well - equipped R&D centre is supported by kilo lab having reactors from 5 lit to 250 lit, SSR/GLR vessels to solve scale-up issues at production. We are very specific in creating online documentations for various phases of process development including the scale-up, safety, and engineering reports which help production to have a safe and robust process and also to support regulatory filings.
We have five state-of-the-art chemical process research laboratories, seven analytical research laboratories, equipped with standard equipment occupying a total area of 7000 sq. ft. Our research team consists of more than 60 qualified scientists with extensive expertise and experience in Process Research and Development activities for Formulations and their critical intermediates. These resources enable us to deliver the solutions to challenging and complex chemistry issues within a stringent timeline.
Analytical R&D
Analytical Research & Development Laboratory at Mickle has skilled and experienced manpower to handle various tasks and provide support to Process Research & Development, Regulatory team, Quality Control Laboratories and also address customer queries.
Analytical Research & Development Laboratory at Mickle has well equipped state of the art facilities for :
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Analytical method development & their method validations
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Establish complete specifications for raw materials, DMF key starting materials, intermediates and Formulation's
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Conducting stability studies for Formulation's as per ICH guidelines to identify proper storage and packing conditions
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Developing method for evaluation of genotoxic impurities and their validations
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Developing chiral methods
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Isolation of impurities by Separation through Flash column chromatography/Prep HPLC and characterization of impurity standards
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Impurity profiling and degradation studies
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Generation of scientific reports and method development reports under cGLP
Analytical Research & Development Resources :
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XRD Laboratories for polymorphic evaluation
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LC-MS Laboratory for identification of trace level impurities during method development
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HPLC Laboratories for routine method development and to provide support for process research & development
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GC / GC-HS Laboratories for method development and RS/OVI development
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UV, IR, Polarimeter, Potentiometer, KF titrator and wet laboratories etc.
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Impurity laboratory for separation and isolation of critical impurities using Flash column chromatography/ PREP HPLC
Achievements of Analytical R&D :
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Analytical R&D has been approved by DSIR.
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Mickle Analytical R&D has contributed USP monograph for Bosentan monohydrate.
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Published several research articles related to stability indicating method development and validations in various national and international journals of Analytical Chemistry.
Analytical R&D Publications:
capabilities
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Well equipped R&D centre with state of the art facilities
Innovative chemical research and process development for new Formulations
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Process development and continuous improvement to meet the cost
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Technology Transfer Team for smooth transfer of process from R&D to Manufacturing through process engineering and pilot plant.
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A dedicated project management team
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Conduct polymorphic studies :
1. Experts in evaluation and exploration of polymorphs using the in-house designed protocol.
2. Spray drying laboratory to explore amorphous solids
3. Synthesis, Identification, characterization and quantification of Polymorphs
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Robust Process Development guidelines and reports
REACTION CAPABILITIES
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Alkylations
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Halogenations
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Amidations
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Hydrazine
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Condensation
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Hydrogenation
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Cyanations
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Nitrations
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Cryogenic
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Oxidations
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Etherification
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Piperazines
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Esterifications
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Reductions
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Formylation
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Resolution Tech.
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Friedel Crafts
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Thiophene
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Grignard
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Witting
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Swern oxidation
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Gewald
Intellectual Property Management
Our policy is to create and manage intellectual property assets by developing non-infringing, novel, cost effective and environmentally friendly processes for Formulation's. Our Philosophy is to respect the intellectual property rights belonging to third parties and customer confidentiality and thus protect customer's interests.
Articles published
Custom Research and Manufacturing Services of Mickle combines: