Kopran

A Global Pharmaceutical Company

Kopran

A Global Pharmaceutical Company

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Active Pharmaceutical Ingredients


Kopran manufactures a range of APIs, including Sterile Cephalosporins and Carbapenems, in its state of the art facility. Manufacturing of Sterile API needs excellent facility and quality systems. Kopran has always been a major player in the manufacturing of Sterile Cephalosporins and Carbapenems. We also offer Macrolide, Antibacterial, Anticonvulsant and Cardiovascular range of drugs. We hold Certificate of Suitability and Drug Master File for many of our APIs.

Accreditations

  • The plant has been approved by US FDA, EU GMP, WHO GMP & KFDA.

Manufacturing Facility


  • The facility is located at K-4/4, Additional MIDC, Post: Birwadi, Tal: Mahad, District: Raigad, Maharashtra, India.
  • The built up area is 11,900 sq. meters on a plot of 36000 sq. meters.
  • The facility has plants for manufacturing:
    • Atenolol
    • Pregabalin
    • Cephalosporins
    • Carbapenems - Non-Sterile & Sterile
    • Macrolides
    • Antibacterials
    • Other APIs

  • The facility has a well-defined Quality Management System according to the current Good Manufacturing Practices.
  • Leveraging on the in house expertise and in house research, this division has concentrated on high value drugs which require technological expertise.
  • The manufacturing facility is well supported by a state of the art pilot plant for scaling-up new products.
  • The facility has been approved by United States Food and Drugs Administration (USFDA) and European Directorate of Quality Medicines (EDQM).
  • The following products have been registered with the USFDA:
    • Atenolol (Approved with ANDA application)

  • The following products have been filed for registration with USFDA:
    • Pregabalin
    • Azithromycin
    • Metaprolol Tartarate
    • Metaprolol Succinate
    • Nitroxoline Dossier has been approved by German Drug Authority has been filed in 15 EU Countries

  • The following products have the EDQM Certificate of Suitability to the European Pharmacopeia (CEP):
    • Atenolol
    • Azithromycin
    • Roxithromycin
    • Pregabalin
    • Lymecycline (under final approval)

Process Capabilities

Production of Chemical Intermediates and Active Pharmaceutical Ingredients by:

1. Acrylation 12. High Pressure Hydrogenation
2. Alkylation 13. Haloganation
3. Amination 14. Mannich Base Reaction
4. Cyclisation 15. Nitration 
5. Condensation 16. Oxidation
6. Chlorosulphonation 17. Oximation
7. Epoxidation 18. Protection and Deprotection
8. Enzymatic Hydrolysis 19. Pressure reaction
9. Esterification 20. Reduction
10. Friedal Craft Reaction 21. Silylation
11. Grignard Reaction

Manufacturing Capabilities


  • Stainless steel and glass-lined reaction vessels ranging from 50 litres to 6000 litres suitable for working under vacuum and atmospheric pressure. Total working capacity of all the vessels is 127,000 litres
  • Hydrogenation facility with working pressure upto 30 bar
  • Facility for cryogenic reactions at (-) 95°C.
  • Palletisation and granulation facility
  • Solvent distillation facility
  • Supporting equipment, like, centrifuge, agitated nutsche filter dryer, nutsche filter, vacuum tray dryer, rotary cone vacuum dryer.
  • Micronizing facility for particle size reduction
  • Dedicated facility for manufacturing sterile products
  • Quality testing laboratory equipped with audit trail complying instruments
  • Microbiology testing facility
  • Separate warehouses for synthetic and semi-synthetic raw materials and finished products
  • Plants for Purified Water, Water for Injection and Pure Steam generation
  • Supporting utilities, like, steam boiler, cooling tower, chilled water and chilled brine plants, compressed air and nitrogen generation plants, back-up diesel generating set for electricity
  • Effluent treatment plant with installed capacity for treating 250 KL per day effluent

The manufacturing plants are suitable for production of various organic intermediates and Active Pharmaceutical Ingredients. Our rigorous compliance to cGMP norms assures the high quality standard of our products.

Extensive experience in Organic Chemistry coupled with cGMP capabilities allows Kopran to provide its customers with a wide range of services in Organic Synthesis for custom manufacturing and the production of Active Pharmaceutical Ingredients.

The team of dedicated scientists with a state of the art Research Centre supported by Pilot Plant can meet the challenges of increasing customer demands. The independence of the research team means that customers are assured that Contract Research is carried out confidentially and exclusively.

Also, as part of our responsibility towards environment protection we are continuously putting efforts towards pollution and energy reduction.