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GMP manufacturing

Advanced technology.
Superior quality.

From route selection in the laboratory to a validated commercial process — every step is documented, controlled and auditable, and every batch is released by our own QC laboratory.

15+
Years of practice
35+
Products made
100%
Batches QC-released

From route to release

One controlled path, six stages

Each stage hands a documented result to the next, so what reaches you can be traced back to the bench.

Stage 01 · Research & Development

Route selection in the laboratory

Alternative synthetic routes are evaluated at bench scale on cost, safety and impurity profile before one is chosen.

  • Route scouting at bench scale
  • Impurity profile mapped early
  • NDA before any disclosure

Stage 02 · Process Development

Defined before it is scaled

Critical process parameters are fixed and a pilot campaign proves the route transfers to plant equipment without being re-engineered.

  • Critical process parameters defined
  • Pilot campaign before scale-up
  • Validated cleaning between products

Stage 03 · Manufacturing

Multi-purpose reactor trains

Glass-lined and stainless steel reactors from pilot to commercial scale, configured per campaign and run under GMP.

  • Jacketed control, −20 °C to 150 °C
  • Change control and deviation handling
  • Full batch record retention

Stage 04 · Quality Testing

Released by our own QC laboratory

Every batch is tested against a documented specification before it is allowed to leave the plant.

  • HPLC, GC and UV-Vis
  • IR, Karl Fischer and wet chemistry
  • In-process and finished-product checks

Stage 05 · Packaging

Packed to protect the molecule

Double LDPE liners in HDPE drums or fibre drums, nitrogen flushed where the molecule requires it.

  • Double LDPE liners
  • HDPE or fibre drums
  • Nitrogen flushed where required

Stage 06 · Dispatch & Delivery

Documented with every consignment

Each consignment leaves with the paperwork your QA team needs to release it, and ships to formulators across India.

  • Certificate of Analysis and MSDS
  • Residual solvent statement
  • Elemental impurity statement

Inside the plant

Built for controlled, repeatable chemistry

Reactors, laboratory and quality systems under one roof — so a batch never waits on someone else's schedule.

The Harvin labs manufacturing building at GIDC Panoli, seen from above
GIDC Panoli, Ankleshwar

Multi-product manufacturing campus

Dedicated blocks, utilities and storage on one site.

Multi-purpose reactors

Glass-lined and stainless steel reactors from pilot to commercial scale, with jacketed temperature control.

−20 °COperating range150 °C

In-house QC laboratory

  • HPLC
  • GC
  • UV-Vis
  • IR
  • Karl Fischer
  • Wet chemistry

GMP systems

  • Change control
  • Deviation handling & CAPA
  • Validated cleaning
  • Batch record retention

Process validation

3 consecutive validation
batches before release

Controlled packing

Double LDPE liners in HDPE or fibre drums, nitrogen flushed where the molecule requires it.

Black solvent storage tanks and the tanker bay at the Harvin labs plant

Utilities & solvent storage

Managed on site, segregated by product campaign.

Dispatch documentation

Supplied with every consignment:

  • Certificate of Analysis
  • MSDS
  • Residual solvents
  • Elemental impurities

By the numbers

15+
Years
35+
Products
500+
Clients served

Made in Panoli, Gujarat — supplied to formulators across India

Plant capacity

Capacity and reaction capabilities

Multi-purpose trains configured per campaign, so a route developed at pilot scale transfers to commercial volume without being re-engineered.

Chemistry outside this list is assessed case by case. Send us the route

Reaction capabilities

  • 01 Grignard reactions
  • 02 Halogenation & bromination
  • 03 Friedel-Crafts acylation
  • 04 Catalytic hydrogenation
  • 05 Nitration
  • 06 Esterification & hydrolysis
  • 07 Condensation
  • 08 Diazotisation
  • 09 Alkylation
  • 10 Oxidation & reduction
  • 11 Cyclisation
  • 12 Chiral resolution

CDMO

Contract manufacturing.
Your chemistry stays yours.

Confidential, end-to-end contract manufacturing — from route evaluation and process development through to validated commercial supply, under a single agreement and a single point of contact.

Dedicated campaigns run with segregated documentation and cleaning verification between products.

  1. Step 1

    Confidential by default

    NDA before disclosure; your route is never cross-referenced or reused.

  2. Step 2

    Route & process development

    Alternative routes evaluated on cost, safety and impurity profile.

  3. Step 3

    Scale-up & validation

    Pilot campaign, then three consecutive validation batches.

  4. Step 4

    Regulatory support

    Documentation and data packs to support your regulatory filings.