API Manufacturing

Through strategic JV’s and partnerships, Neopharma now has a world-class API manufacturing facility in the city of Hyderabad, capable of handling new, complex and hazardous reactions. Neopharma supplies NCEs, cGMP intermediates and KSMs to global innovators. It is equipped with flexible, versatile and advanced infrastructure, tailored to fit any complex chemistry molecules. The manufacturing facilities comply with all regulatory guidelines and requirements of current Good Manufacturing Practices (cGMP) and are successfully inspected/approved by health and regulatory agencies.

Our expertise in intellectual property and regulatory issues helps us consistently deliver the highest quality API's that meet or exceed regulatory standards.

Key Features:

  • Six production blocks spread over 7 acres, and a mini-plant for scaling up of new products.
  • Total reactor volume of 292 KL, with over 70 reactors with a balance of Stainless steel and glass lined reactors
  • Capable of handling broad spectrum of reactions and wide range of process parameters.
  • The facility is CGMP certified.
  • WHO GMP approved, ISO 9001:2000 certified; OHSAS and ISMS Certified.
  • Planned certifications by: USFDA, EDQM, BfArM (Germany), TGA (Australia) and PMDA (Japan), AFSSAPS (France), ANVISA ( Brazil) and Cofepris ( Mexico).
  • Manufacturing base of high value/ low volume and low value/ high volume products.
  • Zero discharge facility with biological treatment, multiple-effect evaporators and reverse osmosis systems.
  • 3 clean rooms (Class 100,000) with 70L, 500L and 2000L crystallizers.