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India advantage for cost-efficiency and supply stability
Green chemistry solutions in tune with our commitment to science-based targets (SBTi)
Excellent regulatory track record with zero observations; drug product quality-on-time-in-full of 90%
Flexible and customer-centric solutions such as dedicated centers, FFS, FTE, and risk-reward models.
- Drug Substance
- Drug Product
Drug Substance
We offer comprehensive process research and development services as well as cGMP manufacturing services to help clients with investigational to commercial-scale development programs. We cater to several industries including pharmaceuticals, specialty chemicals, agrochemicals, polymers, oligonucleotides, animal health, and consumer products.
Our development capabilities include advancing highly potent active pharmaceutical ingredients (HPAPI) and oligonucleotides with therapeutic and diagnostic applications, from laboratory to manufacturing scale. We also have expertise working with performance chemicals and specialty materials using synthetic organic chemistry and polymer chemistry.
Key features
- Hastelloy cryogenic reactors that are temperature-controlled and have a large capacity
- Hydrogenators with no reactivity or material of construction to be worried about
- cGMP capability ranging from 50g to 30MT
- Capability to manufacture HPAPI up to band 4/5 (0.01ug/m3) under cGMP conditions
- Significant experience in manufacturing drug substances for PROTACs, TIDES (oligos and peptides), ADC, and animal products
- Dedicated non-GMP site enabling cost-effective, small-scale development projects for clients
- Large-scale reactive metabolites and active ingredient production site that is cost-effective and backward integrated for large-scale manufacturing (expandable)
Drug Product
We offer Formulation Development services to help clients determine optimal dosage levels for therapeutic formulations in oral solid, liquid, and injectable forms. Our integrated services extend to new chemical entities (NCE), late-phase product development, and over-the-counter products with a focus on quality, speed, and cost-efficiency.
We cater to pharmaceutical companies worldwide, providing extensive pre-formulation studies, toxicology formulation, formulation development, and analytical method development and validation. Our services include conducting stability studies as per ICH guideline, regulatory dossier preparation, process optimization, scale-up activities, and manufacturing of clinical and commercial batches in a cGMP environment.
Key features
- Sterile fill finish for small molecules and biologics: ~14-15million vials/yr/filling line; three filling lines
- Capability to offer drug product manufacturing from early to late phase through to commercial manufacturing
- Experience in drug product manufacturing for orphan and rare diseases
- Capacity availability for small-size manufacturing requirements
- Zero instances of 'refusal to file'
- Enabled fast-track approval for NDAs (<2 years)
Key features of our small molecule facilities
Scale of operations
- Reactor size range from 60 L to 12.5 KL
- Broad range of Reactors (Stainless steel, Glass lined, Hastelloy)
- 12 KL cryogenic reactor operating within a temperature range of -90°C to 140°C
- Hydrogenator for highly acidic/basic reactions with capacity up to 4 KL and 26 bar pressure rating
- High vacuum (< 10 Torr) & high temperature (140°C) distillations
Licenses
- Consent for Operations
- PESO license for solvent storage
- No objection certificate from Karnataka state fire emergency services (KSFES)
- Poison license from state Government authority
- Hazardous waste disposal
- Factory license from Director of Factories
Zero discharge
- Effluent from the processes and utilities treated thermally, biologically
- Biologically treated effluent subjected to reverse osmosis (RO)
- RO output is reused in the utilities
Automation
- Distributed control system (DCS) operated plant
- Accurate auto solvent transfer sequences by avoiding human intervention
Biologics manufacturing
- cGMP manufacturing capacity for mammalian (200L/500L and 2000L) using single-use bioreactors and up to 500L scale using stainless steel fermenters for microbial
- Sterile Fill-Finish facility to manufacture ready-to-use solutions and lyophilized products (pre-sterilized vials and PFS) OEL: ≥ 1 µg /m3 in GMP environment
- Only GLP/GMP Viral Testing facility in India for batch release and viral clearance testing – phase 1 to commercial
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Brochures
Small Molecule Development and Manufacturing
Syngene offers chemical development, formulation, analytical, clinical development, and manufacturing services across small molecules, oligonucleotides, HPAPIs, and performance and specialty materials.
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