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Manufacturing Facilities


Being one of the leading manufacturers of API's products in India, we are equipped with sophisticated manufacturing facilities. An organization's capabilities and intent are strongly reflected in the product it manufactures.Our dedication and loyalty for providing excellent quality products are our strength that strongly reflects in our products. We have GMP Certified manufacturing facility, separate section for steriod & a dedicated plant for intermediates.

ManufacturingManufacturing

Our Manufacturing Facilities adheres to the following :
  • Clearly defined manufacturing processes, which are periodically reviewed and are capable of consistently manufacturing products of specified quality.
Manufacturing

  • All critical stages of the manufacturing procedure and changes to the same are validated.
  • Provision of qualified, trained personnel, adequate premises and space, equipment and services, correct material, approved procedures and work instructions, suitable storage and transport.
Manufacturing

  • Records are made and entries maintained at all critical stages of manufacturing to demonstrate adherence to procedures and attain expected-quality and yield of product. Manufacturing records are retained in comprehensible formats so as to achieve traceability.
  • Availability of a system to recall any batch of a product from sale or supply.
  • Investigation of market complaints and in house non-conformances, corrective and preventive action.
  • Recording of deviations, incidents, changes and investigations of the same.



Chemistry Offered


  • TRIAZOLYL COMPOUNDS
  • CATALYTIC REDUCTION (HYDROGENATION)
  • PHASE TRANSFER REACTIONS
  • BENZYLATION & DEBENZYLATION
  • ALPHA BROMINATION
  • IMINE CHEMISTRY ( Schiff Base)
  • RESOLUTION OF OPTICAL ISOMERS
  • SEPARATION OF GEOMETRICAL ISOMERS



Quality Assurance


Our Quality Assurance (QA) ensures the following :
  • GMP and GLP are taken into account while designing and developing products.
  • All production and control operations are clearly specified and documented.
  • Key personnel responsibilities are clearly defined.
  • All arrangements for procurement and use of correct starting materials and packaging materials are made.
  • Inprocess checks and validations are carried out in a defined manner.
  • The final product is manufactured, packed and checked as per defined procedures.
  • Regulatory aspects as well as internal requirements for the final product are fulfilled, and the product is released for supply or sale only after necessary certification by a qualified person.
  • Storage, handling and distribution procedures for the final product are followed to ensure maintenance of quality throughout shelf life.
  • Self-inspection procedures are defined to regularly monitor the effectiveness of the Quality Assurance system.



Quality Control


Our Quality Control (QC) ensures the following :
  • Approved procedures, trained personnel and adequate facilities for sampling, inspection and testing of starting materials, packaging materials, intermediate, bulk and finished products, and for monitoring environmental conditions where necessary.
  • Validated test methods.
  • Maintenance of records to demonstrate that all procedures have been carried out.
  • Certification of starting materials to be of specified quality and purity, and their storage and adequate labeling before use in final product.
  • Release of a batch of a product only after certification by a Qualified person that it meets required criteria or specifications.
  • Maintenance of sufficient retention samples of starting materials and final product for future examination if necessary.
  • Recording and investigation of out of specification results, changes, incidents/ deviations.



Regulatory Strength

  • DMF in CTD format is available for almost all the products manufactured by us.
  • ISO 9000-2001 Certified Company.
  • GMP approved facility.
  • Certified by MOH JAPAN, & INFARMED PORTUGAL
  • Our facilities are approved by various customer across the globe.




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Our Products : -   Active Pharmaceuticals Ingredients (API's)  |  Drug Intermediates   |  New Launch Products
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