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Manufacturing

Production:

Vial line 1

Capacity: 36 Million vials/year

Batch size: 15 to 1000Lit

Aseptic and Terminal sterilization

Ampoule line

Capacity: 72 Million ampoules/year

Batch size: 15 to 400Lit

Aseptic and Terminal sterilization

Vial line 2 with Lyophilizers

Capacity: 2.5 Million vials/year

Batch Size: Upto 200 Lit 

Fill Volume: 1mL to 50mL

Two 13 Sq.m Lyophilisers

Vial Line 3

Capacity: 40 Million vials/year

Batch size: 15 to 1,500 Lit

Aseptic and Terminal sterilization

Regulatory:

Our regulatory team has extensive experience in filing dossier across the globe. Our dossiers have been approved without any major queries in US, Canada, Europe, Australia, UK, LATAM , South East Asia, CIS and Africa. We do provide product development guidance, regulatory strategy, gap analysis of the dossier for site transfers, dossier compilations, control correspondence with agency, query response and approval

Quality Control Lab

Quality Control:

The Quality Control lab is spread across 3500 Sq. Ft.

  • Physical & chemical analyses of the raw materials and finished products
  • Microbiology testing
  • Stability testing for all four zones

Chemical Lab:

  • HPLC with Auto sampler
  • Atomic Absorption Spectrophotometer (AAS)
  • IR, UV, DO meter
  • Liquid Particle counter
  • ICP-MS
  • LC-MS
  • GC-MS
  • IC
  • GC & HPLC

Microbiology Lab:

  • Sterility, BET, MLT, Bio assay, Vitek II