DSIR-recognised R&D · ISO-certified · Chennai, India

From pharmaceutical science to commercial scale.

KMS Pharma is a pharmaceutical development and technology partner. We take complex products—oral solids, oral liquids, topicals, sterile injectables and ophthalmics—from formulation and analytical science through technology transfer, regulatory work and commercial supply.V-03

About KMS

Development that survives every handover.

KMS Pharma works with pharmaceutical companies on novel drug delivery systems, custom product development and complex or niche products, from the first formulation through clinical study, dossier and supply.

Programmes rarely fail because of a single laboratory, site, or consultant. More often, they stall at the handovers between them.

At KMS, our formulation, analytical, technology-transfer and regulatory scientists work as one integrated programme team. This ensures continuity from development through commercialisation—with the same technical understanding carried across every stage.

The product that leaves our laboratory is developed with the same end goal in mind: to reach the market successfully.

Products developed at KMS have been approved by regulators including the US FDA, the UK MHRA and Health Canada.V-07

One team
Formulation, analytical, technology-transfer and regulatory scientists on the same programme.
Complex products
Complex generics, novel drug delivery systems, sterile products, topical formulations, and differentiated reformulations across diverse therapeutic areas.
To the market
Dossiers, bioequivalence through research partners, and commercial supply.
Complexity → productOral solids · liquids · topicals · sterile · ophthalmic

Quality

Quality is a sequence, not a checkpoint.

Quality starts at the target product profile, not the final test. Critical quality attributes are defined before the first batch, risks are assessed before a process is fixed, and methods are validated before anyone relies on their data.

The quality loop · six stages
  1. 01

    Define

    QTPP and CQAs

  2. 02

    Design

    QbD and DoE

  3. 03

    Verify

    Validated methods, ICH stability

  4. 04

    Control

    CPPs and design space

  5. 05

    DocumentV-25

    cGMP/cGLP-aligned records

  6. 06

    Improve

    OOS/OOT investigation, continuous improvement

  • DSIR-recognised in-house R&DV-03Govt. of India
  • ISO-certified quality management systemV-04QMS

An unvalidated method is an opinion. Our partners file the data we generate, so the data has to hold up to a reviewer.

How quality works at KMS

Capabilities

Six development capabilities, plus independent audit. One accountable team.

Engage us for a single study or an entire programme. Each capability stands on its own, and each one is built to hand over cleanly to the next.

Not sure where your programme fits? Tell us the molecule and the market, and we will tell you where we would start.

Start a Conversation

The development journey

From molecule to market.

01 / 07

Stage 01

Molecule

Understand the molecule before designing the product.

Analytical threadPreformulation studies · intrinsic dissolution

Product portfolio

A portfolio ready to partner.

Alongside partner programmes, KMS develops its own generic dossiers, differentiated products and nutraceuticals. Each one is available for licensing, co-development or supply.

Generic dossiers
20
Generic dossiers in preparation for EU, US and RoW markets
Differentiated products
17
Differentiated products: oral liquids, RTU injectables, topicals, modified release
55 products
Seven filled · one released
Selected products
ProductMarketStatus
Tofacitinib citrateEU/USJun 2027
Ferric carboxymaltoseEU/USJul 2027
Brimonidine tartrateEU/USMay 2027
Tafluprost (preservative-free)EU/USJun 2027

Global reach

Developed in Chennai, for regulated markets.

Every programme is run from one site in Chennai and documented to the expectations of the market it will be filed in: the US FDA, European authorities, or regulators elsewhere. Select a market to see what that means in practice.

Chennai, India

R&D and programme management

Our laboratories in Selaiyur, where every formulation, analytical and regulatory decision is made.

Select a location

Leadership

Meet the People
  • Portrait of Dr M. Ganesan

    Dr M. Ganesan

    Founder & Managing Director

  • Portrait of Ms Vasanthi

    Ms Vasanthi

    Director, Project Management

  • Portrait of Dr S. John Prasanna

    Dr S. John Prasanna

    Senior Analytical Consultant

Full leadership roster to follow.V-22

Our clients

Companies we have worked with.

  • Sun Pharma

    Sun Pharma

  • Cipla

    Cipla

  • Mankind

    Mankind

  • MSN

    MSN

  • Shilpa

    Shilpa

  • Eywa Pharma

    Eywa Pharma

  • Atnahs

    Atnahs

  • JAMP Pharma

    JAMP Pharma

  • Bionpharma

    Bionpharma

  • Nivagen Pharmaceuticals

    Nivagen Pharmaceuticals

  • Xepa-Soul Pattinson

    Xepa-Soul Pattinson

  • Remedica

    Remedica

  • Celltrion

    Celltrion

  • Acino

    Acino

  • Biopharm

    Biopharm

  • Changzhou Pharmaceutical Factory

    Changzhou Pharmaceutical Factory

  • Developharma

    Developharma

  • Neo Health

    Neo Health

Our motto

Putting health first.

Every development decision here is measured against the person who will take the medicine. That is what keeps our data defensible, our processes reproducible and our timelines honest.V-02

The Managing Director of KMS Pharma at his desk
Managing DirectorKMS Pharma · Chennai

Start a conversation

Where does your programme stand?

Tell us the molecule, the dosage form and the market you are filing in. A programme lead will read it and reply with what we would do next.

Business enquiries: vasanthi@kmshc.com · +91 97898 75194V-23

KMS PharmaChennai