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.
- DSIRV-03In-house R&D recognised by the Department of Scientific and Industrial Research, Government of India
- ISOV-04Quality management system certified to ISO standards
- 100+V-05Scientists across formulation, analytical development and technology transfer
- US · EU · RoWMarkets our development programmes are built to satisfy
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.
- 01
Define
QTPP and CQAs
- 02
Design
QbD and DoE
- 03
Verify
Validated methods, ICH stability
- 04
Control
CPPs and design space
- 05
DocumentV-25
cGMP/cGLP-aligned records
- 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.
Formulation DevelopmentOral solids
- 01Formulation DevelopmentDosage forms designed against the target product profile, not against the clock.Oral solids · Oral liquids · Semi-solids · Sterile · 15 sterile formats
- 02Analytical DevelopmentMethods developed alongside the product, so the data is ready when the dossier is.LC-MS/MS · GC-MS · ICP-MS · Nitrosamines · IVRT/IVPT
- 03Technology TransferTurning development knowledge into a process the receiving site can run reproducibly.Scale-up · Exhibit batches · Site-to-site transfer
- 04Regulatory AffairsRegulatory judgement applied from the first experiment to the final query response.Dossier development · Compilation · Query resolution
- 05BA/BE & ClinicalBioequivalence and clinical studies managed through established research partners.BA/BE study management · Clinical trials via Voxtur Clinical Research
- 06Commercial SupplyFrom development batches to dependable supply through a qualified manufacturing network.Manufacturing network · US · Europe · RoW
- 07Third-Party Audit & Compliance AssuranceIndependent technical and regulatory assurance for pharmaceutical, clinical research and BA/BE organizations.BA/BE · Clinical & CRO · GMP manufacturing audits
Not sure where your programme fits? Tell us the molecule and the market, and we will tell you where we would start.
Start a ConversationThe development journey
From molecule to market.
01 / 07
Stage 01
Molecule
Understand the molecule before designing the product.
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
| Product | Form | Market | Status |
|---|---|---|---|
| Tofacitinib citrate | Oral solution | EU/US | Jun 2027 |
| Ferric carboxymaltose | Injection | EU/US | Jul 2027 |
| Brimonidine tartrate | Gel | EU/US | May 2027 |
| Tafluprost (preservative-free) | Ophthalmic solution | EU/US | Jun 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
Dr M. Ganesan
Founder & Managing Director

Ms Vasanthi
Director, Project Management

Dr S. John Prasanna
Senior Analytical Consultant
Full leadership roster to follow.V-22
Our clients
Companies we have worked with.

Sun Pharma

Cipla

Mankind

MSN

Shilpa

Eywa Pharma

Atnahs

JAMP Pharma

Bionpharma

Nivagen Pharmaceuticals

Xepa-Soul Pattinson

Remedica

Celltrion

Acino

Biopharm

Changzhou Pharmaceutical Factory

Developharma

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

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
