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Manufacturing Services in India

Services

Together with our longstanding network of carefully selected INDIAN associates and unique subcontractors (CRO/CDMO) that are fully committed to comply with our various agreements and policies we are offering a reliable, comprehensive and transparent service for:

Custom / Contract Manufacturing / Tolling (CRAMS/CMO)
Custom synthesis on FTE & FFS service model (CRO)
Literature and Patent Research
Process Research
Process Development
Bench-Scale Lab, Kilo Lab and Pilot Plant Development
Process Optimization
Commercial manufacturing

Core Technologies

Acetylene chemistry
Boronations
BuLi (on MT levels)
Catalytic hydrogenation
Coupling reactions (Suzuki / Stille and others)
Cyanations
Diazotizations
Fluorination large scale performing fluorination with HF, KF, F2 gas, and SF4
Grignards
Halogenation
Heterocylic chemistry / complex molecules
(e.g. Pyridines, Pyrimidines, Indoles, Benzimidazoles, Tetrazoles,…)
Hydrogenations
Nucleoside chemistry
Reductions

Scales:
Pilot scale: in the range of 1 kg – 100 kg
Commercial scale: reactors capacities (in m3) vary from 1 to 25

Reactor types:
SS, MS (rare), GL and Hastelloy reactors
In case of catalytic hydrogenation, reactor pressures are in the range of 5-20 kg/cm2
Cryogenic reactors can be set up for long term projects


 

Further Highlights of our services we are providing out of India


Medicinal Chemistry
Hit to Lead Development
Lead Optimization with a focus on improving potency and efficacy
Lead compound scale-up for advanced studies
Synthesis of new scaffolds of any structural complexity
Problem solving – synthetic discovery, SAR analysis, ADMET related issues
Multiple therapeutic area expertise

Analytical services such as
GMP analytical services (EU-GMP and USFDA)
AMD/AMV development & technology transfer
Nitrosamine screening
Elemental Impurities Studies [ICH Q3 D]
Impurity isolation and characterization

Compliance offerings

Compliance offerings

  • cGMP (pharma), Pharmacopeia grades, US-FDA / EMA accredited facilities
  • cGMP (food), Food grade, FCC, Kosher, Halal, HACCP, non-GMO, Vegan
  • GMP+ (feed)
  • ISO 900x
  • REACH