DSIR-recognised R&D · ISO-certified · Chennai, India
Pharmaceutical Company for Drug Development, R&D and Commercial Supply.
KMS Pharma is a pharmaceutical company and development partner supporting pharmaceutical businesses from early-stage formulation and analytical development through technology transfer, regulatory support and commercial supply. Our expertise spans oral solids, oral liquids, topical formulations, sterile injectables and ophthalmic products, with a focus on complex, niche and differentiated pharmaceutical products.V-03
About KMS
A pharmaceutical company connecting development with commercial supply.
KMS Pharma is a pharmaceutical company supporting the development and commercialisation of complex, niche and differentiated pharmaceutical products. Our work covers novel drug delivery systems, custom product development and complex formulations, taking programmes from early formulation and analytical development through technology transfer, regulatory documentation and commercial supply.
Pharmaceutical development often involves multiple teams, facilities and technical stages. The challenge is maintaining product knowledge and development intent as a programme moves from one stage to the next. At KMS, formulation, analytical, technology-transfer and regulatory scientists work together as one integrated team, helping maintain continuity from development through commercialisation.
Formulation, analytical, technology-transfer and regulatory scientists work together across the programme, helping reduce gaps between development, scale-up and commercialisation.
Our capabilities include complex generics, novel drug delivery systems, sterile products, topical formulations and differentiated reformulations across diverse therapeutic areas.
KMS Pharma supports programmes beyond laboratory development, including technical documentation, technology transfer, bioequivalence through research partners and commercial supply.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 is built into pharmaceutical development from the target product profile, not added at the final test. KMS Pharma defines critical quality attributes early, assesses formulation and process risks, and develops validated analytical methods to support reliable pharmaceutical development. Our approach combines Quality by Design (QbD), analytical development, ICH stability studies and process understanding, helping connect formulation science with technology transfer, commercial manufacturing and regulatory requirements.
- 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 development built for commercial scaleOral solids
- 01Formulation development built for commercial scaleDosage forms designed against the target product profile, not against the clock.Oral solids · Oral liquids · Semi-solids · Sterile · 15 sterile formats
- 02Analytical Development That Supports Confident Pharmaceutical DecisionsMethods developed alongside the product, so the data is ready when the dossier is.LC-MS/MS · GC-MS · ICP-MS · Nitrosamines · IVRT/IVPT
- 03Technology Transfer CompanyTurning development knowledge into a process the receiving site can run reproducibly.Scale-up · Exhibit batches · Site-to-site transfer
- 04Regulatory Affairs CompanyRegulatory 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 Supply CompanyFrom 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 Pharma develops its own generic dossiers, niche pharmaceutical products, injectables and nutraceuticals. Selected products are available for licensing, co-development and commercial supply, offering pharmaceutical companies opportunities to access differentiated products and development programmes.
- Generic dossiers
- 21
- Generic dossiers in preparation for EU, US and RoW markets
- Niche products
- 17
- Niche products: oral liquids, RTU injectables, topicals, modified release
| Product | Form | Market | Status |
|---|---|---|---|
| Semaglutide | Capsule | EU/US | Jun 2027 |
| Tofacitinib citrate | Oral solution | EU/US | Aug 2027 |
| Ferric carboxymaltose | Injection | EU/US | Jul 2027 |
| Brimonidine tartrate | Gel | EU/US | Jul 2027 |
| Tafluprost (preservative-free) | Ophthalmic solution | EU/US | Jul 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