Manufacturing facility

Manufacturing facility

Laxai has a world-class API manufacturing facility in the city of Hyderabad, capable of handling new, complex and hazardous reactions. Laxai 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 churning out of Innovator’s development pipelines. The manufacturing facilities complies with all regulatory guidelines and requirements of current Good Manufacturing Practices (cGMP) and are successfully inspected/approved by health and regulatory agencies. Laxai has a road map to upgrade the facility to US-FDA standards in a span of 24 months.

Key features of the facilities:

  • Six production blocks spread over an area of 7 acres, and a mini-plant for scaling up of new products.
  • Total reactor volume of approximately 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, and plans to be certified by US FDA, EDQM, BfArM (Germany), TGA (Australia) and PMDA (Japan), AFSSAPS ( France), ANVISA ( Brazil) and Cofepris ( Mexico) soon.
  • It is also WHO GMP approved and ISO 9001:2000 certified; OHSAS and ISMS Certified.
  • Manufacturing base typically consists of high value/ low volume and low value/ high volume products.
  • A 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

These features ensure an effective structural methodology at workplace which includes manufacturing of quality products, rational and effective use of available resources, minimization of waste along with good safety and hygiene standards.  Safety aspects have been given utmost importance, in all aspects including plant installation, equipment, systems and trained personnel to ensure smooth productivity.  Combination of a dedicated team and world class production techniques guarantee delivery of products to customers across the globe.

Clean room facility:

manufacturing-4
manufacturing-5
manufacturing-6
manufacturing-3

For details on product offerings contact us at : info@therapiva.net