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Manufacturing Services 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

TIDES: Nucleotides, Oligonucleotides and Peptides

Oligonucleotides:
Small to commercial-scale cGMP and non-GMP manufacturing by liquid phase synthesis (LPS)
Small-scale by solid phase synthesis (SPS)
Custom manufacturing with modifications to backbone linkages, sugars, bases
Multi-scale cGMP and non-GMP manufacturing of side-chain and linker drug modifiers

Multiscale cGMP and non-GMP manufacturing of high-purity nucleotides including nucleoside phosphoramidites

Peptides:
Small to commercial-scale cGMP and non-GMP manufacturing by liquid phase synthesis (LPS)
Small-scale manufacturing by solid phase synthesis (SPS)
Custom synthesis of natural and unnatural amino acids
Multi-scale cGMP and non-GMP manufacturing of side-chain and linker drug modifiers

Complex synthesis including ADC linkers, payloads and Conjugates

Development
scale-up and
commercial manufacturing of linkers-payloads

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