Capabilities

What We Are Equipped to Do

From analytical verification to documentation packaging to logistics, NK Industries manages the full post-sourcing workflow. Here is what that looks like in practice.

Sourcing Network

50+ Qualified Manufacturers

Active relationships across Gujarat, Maharashtra, Telangana, and Tamil Nadu.

Regulated and Research-Grade Partners

cGMP-qualified partner facilities for regulated supply; specialist fine chemical manufacturers for research-grade materials.

Multi-Product Consolidation

Single source for multi-product orders from different manufacturing locations.

Import Channel

IEC BPLPK4014D for specialty materials from international sources.

Export Capability

Certified material export per IEC terms to international pharmaceutical buyers.

Backup Sourcing

At least two qualified sources maintained for critical repeat materials.

Analytical Verification

Every batch is analytically verified before dispatch. We do not relay manufacturer COAs without independent verification for critical materials. Analytical work is conducted through qualified partner analytical labs with calibrated, maintained instruments.

HPLC / UPLC (purity, related substances)
NMR (1H, 13C): structure confirmation
LC-MS / LC-HRMS (molecular weight, fragmentation)
FTIR (functional group characterisation)
UV-Vis spectroscopy
Karl Fischer (moisture)
Melting point
Optical rotation (chiral compounds)
Elemental analysis (selected)
Residual solvents (GC-HS)
Heavy metals (ICP-MS, selected)
Particle size analysis

Documentation

Certificate of Analysis (COA)

  • HPLC purity with method reference
  • Related substances profile
  • Residual solvents (if applicable)
  • Appearance, melting point, optical rotation
  • Batch number, manufacturing date, retest date

Regulatory Compliance Documents

  • MSDS / SDS (GHS format)
  • TSE/BSE declaration
  • Elemental impurity declaration (ICH Q3D)
  • Absence of mutagenic impurities statement
  • ICH Q7 GMP declaration for GMP supply

Spectral Data Pack

  • 1H NMR spectrum
  • 13C NMR spectrum (where applicable)
  • LC-MS or HRMS spectrum
  • FTIR spectrum
  • HPLC chromatogram with method

Batch Genealogy (GMP)

  • Executed batch manufacturing record
  • In-process testing data
  • Raw material COAs and certificates
  • Deviation and CAPA documentation
  • Stability data (where available)

Synthesis Capabilities

Classical organic synthesis
Multi-step route execution
Chiral resolution (classical and enzymatic)
Protective group chemistry
Hydrogenation and reduction
Cross-coupling reactions (Pd, Ni catalysed)
Recrystallisation and purification
Route scouting and optimisation
Forced degradation (ICH Q1B)
Scale-up coordination (g to ton)
Reference batch recreation
Novel impurity synthesis

Packaging and Logistics

Tamper-Evident Packaging

All materials are sealed and labeled for chain-of-custody traceability.

Dual-Label Format

Primary and secondary labels with batch number, CAS, grade, quantity, and hazard classification.

Temperature-Controlled

Cold chain (2–8°C) and ambient-controlled shipping for temperature-sensitive materials.

PO-Linked Reservation

Confirmed purchase orders trigger batch reservation. Material is not released to other buyers.

Domestic Dispatch

48-hour dispatch for in-stock materials. Pan-India courier with tracking.

Export Packaging

Export-compliant packaging, documentation, and logistics per IEC terms.

Compliance References

ICH Q3A/B (Impurities in New Drug Substances/Products)ICH Q7 (GMP for Active Pharmaceutical Ingredients)ICH M7 (Assessment and Control of DNA Reactive Impurities)ICH Q1B (Stability Testing: Photostability)ICH Q3D (Elemental Impurities)FDA Guidance on NitrosaminesGHS Hazard ClassificationIEC BPLPK4014D (Import/Export Code)

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