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ZCL has been concentrating on Research and Development and has scaled up its investments to step-up its capabilities in Generic
research. ZCL R&D activities can be categorized as follows:
1. Research Generic drug development for both small and large molecules for in-house applications
- ZCL's Generic API development meets the speed and quality requirements, as all the elements of research have been conducted within the same location situated at Ankleshwar, Gujarat.
- ZCL could meet up to the standards of all the regulatory agencies, including US FDA, MHRA, ANVISA Brazil and other regulatory agencies.
- Backward integration by in-house intermediate development to efficient Marketing/ Distribution of API products. That give the desired shapes to the generic project from milligram-gram scale development to commercialization.
2. Process Research & Development
- In present pharmaceutical challenging environment, the process research & development chemistry requires to be sharp in the industrial scale chemistry research by not only developing the cost effective processes but also ensuring that processes are protected by Intellectual Property Rights.
- ZCL Process Research & Development will shape on the basic techniques of process engineering and introduce on-line analyzing and control method to yield capabilities for current process development and scale-up together with the creation of very excellent robust commercial scale routes.
- ZCL R&D laboratory is fully equipped for kilogram scale preparation of API and API intermediates. The department has set up a modern pilot plant facility to manufacture multi-kilogram of API and intermediates under cGMP conditions. Apart from small chemical entities.
3. Contract Research and Custom Synthesis
- ZCL Contract Research Team has excellent process scientists to play with the present challenges with synthetic process chemistry. Team has expertise in carrying out a variety of chemical reactions. R&D facility is equipped with international standard fume hoods and walk-in types fume hoods, hydrogenators like autoclaves and other equipments to perform all types chemical reactions.
4. Analytical Research Lab (ARL)
- ZCL has central analytical facility to support Generic Research, Process Research and Custom Research for the Active Pharmaceutical Ingredient (API) and intermediate development for various markets.
- The Analytical Research Lab is equipped with latest equipment to validate and develop analysis techniques as per regulations & it includes:
- Gas Chromatography with Mass Spectrometry
- Gas Chromatographic with Head Space
- FTIR systems
- HPLC Chromatographic Systems
- Gas Chromatographic Systems
Analytical Research (ARL) Team key activities
- To develop the new analytical method and validation as per ICH Guidelines of all molecules.
- To prepare complete specifications for key raw materials, key starting material, API intermediates and Active Pharmaceutical Ingredients as per regulations.
- Transfer, implement of new analytical methods, specifications during R&D trial/validation to production/tech-transfer/QC/QA.
- Stability study of API Substance and the Drug Products as per ICH guidelines
5. ZCL Lab Scale and Plant Scale Chemistry Capabilities
- We are expertise in preparing the small molecules and scale up from milligram scale to gram scale to 500kg scale as per cGMP with required high quality specifications.
- Well equipped to carry out the reaction chemistry at the temperature range between -80°c to +250°C range.
- Ability to make complex organic molecules at lab scale to commercial scale.
- Having facility to scale-up of intermediates and final compounds.
- Multi Stage Synthesis.
- Chiral synthesis and chiral separation using various techniques.
6. Chemistry Handled at Lab & Commercial Scale
- Grignard Synthesis
- Epoxidation Reactions
- Ritter Reactions
- Friedel-Craft Reactions
- Reductive Aminations
- Acylation and Alkylation Reactions
- Sand Meyer Reactions
- Halogination Reactions
- Oxidation Reactions
- Catalytic Reduction Reactions
- Chiral Synthesis
- Various other reactions
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