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