Regulated Market

Regulated Market

Location – Ambernath (View Map)

The Company’s own manufacturing plant is located in Ambernath, on the outskirts of Mumbai. The Plant was commissioned in 2010 and has been equipped with a focus to supply critical APIs to the highly regulated US & EU markets. The plant is WHO GMP certified and US FDA inspected twice (2013 and 2015) and has been found suitable to US FDA regulatory requirement.

This plant is spread over an area of 75,000 sq. ft., which includes Administrative Block, Production Block, Quality Control, Quality Assurance, Warehouse and Utilities.

It is best suited for manufacturing 2 products simultaneously in capacity of gms levels to few hundred kgs level (per month) for API’s and advanced intermediates.

A fully qualified HVAC system including full control of temperature, humidity and room pressure ensures the right environment for quality manufacturing. The facilities at the plant include:

  • Containment class OEB3 (up to 10 µg/m3)
  • Capabilities to handle pressurized reaction upto 50 kg/cm2
  • Capability to handle cryogenic reactions up to -70°C
  • Glass Line Reactors ‐ 1,000 to 1,600L Capacities
  • Stainless Steel Reactors ‐ 500L to 2,000L Capacities
  • Hydrogenator (100 L)
  • Different type of Driers (FBD, TD, RCVD and VTD)
  • Centrifuges, Neutch Filter, High Vacuum Pump, MultiMill, Jet Mill, Shifter, Blenders
  • Quality ‐ HPLCs with auto sampler (UV and PDAdetectors), GC head space with auto sampler, FTIR, UV Spectrophotometer, Stability Chambers as per ICH guidelines, dedicated Microbiology Laboratory with dedicated AHU, TOC Analyzer, Auto Titrators, Digital Polarimeter with temperature controller
  • Utilities ‐ HVAC System comprising of 10 AHUs, 3 FDV Ventilators, Chiller, Boiler, Compressor (oil free) and Generator, UV Water Purification System

Utilities

  • PLC controlled Purified Water System
  • HVAC System comprising of 0.3 µ terminal HEPA filters
  • Oil free, non-lubricated air compressors
  • Nitrogen distribution system for inertisation
  • Brine plant (-25°C )
  • Oil heating system (250°C )
  • Diesel Generator for back up

Warehouse

  • Well-equipped ware house with separate storage areas as per regulatory norms. Solvent are handled through dedicated underground tanks through pipeline
  • Separate storage area for intermediates and finished products stored below 25˚C, 5 ±3˚C and –20 ±5 ˚C