Manufacturing





Our infrastructure & technological capabilities enable us to provide reliable process development and chemical manufacturing services. We undertake the following:

Manufacture of bulk APIs and advanced Intermediates
Contract and Toll Manufacturing
Custom Synthesis
Process development
Scaling up of pilot plant processes to commercial levels

Location
Modern API and Intermediate Manufacturing facilities, at two separate campuses covering around 15 acres at Derabassi near the city of Chandigarh and 250 KM to the north of New Delhi, namely:

Unit-1: Manufacturing Fine Chemicals and Advanced Intermediates.
Unit-3: EuGMP, US FDA, Japanese PMDA compliant API manufacturing facility.

API MANUFACTURING UNIT (Zero Liquid Discharge Facility)

Equipment
Approx. 268 KL (100 Reactors)

Area
450,000 Square Feet

Facility
  • Total of 8, Class 10,000 qualified powder process areas
  • Multipurpose plant with separate high-pressure vessel block
Pilot Plant / Kg Scale Facility
  • 2 Pilot Plants cGMP compliant
  • 1 Kg Scale facility (Dedicated for HPAPI production
HP-API Block
  • Isolator Block: Dedicated to KG scale production of High Potent APIs

INTERMEDIATE MANUFACTURING UNIT

Equipment
  • 60 KL (26 Reactors)
Area
  • 105,000 Square Feet
Facility
  • Multipurpose cryogenic reactions, high-volume distillation
  • Expertise in nuclear and side chain halogenations
New Campus
  • New API & Intermediate facility under construction (Total area: 22 acres)
  • Proposed capacity: 12-14 manufacturing blocks including high pressure and solvent recovery blocks
  • Underground tankage
  • High Potent API facility
  • Phase-I to go on stream by 2020

QA and Regulatory

Quality Control

Fully equipped in-house laboratory including:

  • Dedicated Microbiological Lab
  • Wide range of sophisticated 21-CFR-Part 11 compliant Analytical Instruments
  • Lab is well equipped to comply to upcoming ICH Q3D requirements of “Elemental Impurities” with In-House “ICPMS”
Regulatory Approvals
  • EU GMP certified by Danish Medical Agency (2008, 2015), Berlin & Koln
  • WHO (Geneva) GMP Empanelment for Diethyl Carbamazine Citrate
  • MFDS Korea for Dexketoprofen Trometamol
  • 3rd USFDA for Homatropine Methyl Bromide – March 2018 – EIR received
  • TGA Australia Empanelment
  • Japanese PMDA for Pregabalin- May 2019