Infrastructure

Pharmaceutical Development & Analytical Science

Oral solids, sterile products, ointments and topical semisolids, liquid orals and analytical science are developed on one site in Selaiyur, so a formulation question and the instrument that answers it are a corridor apart. Every instrument listed here is one our scientists work on.
Development and analytical laboratories
5
Development and analytical laboratories
Process and analytical instruments
35+V-24
Process and analytical instruments
Stability and photostability chambers
ICH
Stability and photostability chambers
ACG fluid bed processor in the oral solid process lab01 Oral solid process
Samples prepared under a laminar airflow unit02 Sterile development
Analytical laboratory with HPLC and dissolution systems03 Analytical
Selaiyur, Chennai5 laboratories · one site

01

Oral solid process lab

Granulation, pelletisation, compression and coating at bench and pilot scale.

Nine process routes can be tried on the same molecule and taken to pilot scale here, so the route is chosen on evidence rather than on what the laboratory happens to own.

  • Fluid bed processor (FBP) with top-spray and Wurster columns, ACG
  • Fluid bed dryer
  • Rotary compression: Cadmach 17-station and Karnavati 10-station, D and B tooling
  • Roll compactor
  • Extruder and spheroniser, Fuji Paudal
  • Air-jet mill; multi mill, Becto Chem
  • Octagonal blender (3 L, 7 L); double-cone blender (3 L, 5 L)
  • Auto-coating machine, Neocota; conventional coating pan
  • Encapsulation machine, MF 300
  • High-pressure homogeniser, GEA Niro Soavi Panda Plus; lab-scale homogeniser
  • Vibratory sifter, Becto Chem; sieve shaker, Electrolab
  • Blister pack machine; induction cap sealing machine
  • Moisture analyser, Mettler Toledo; tap density, disintegration and hardness testers

02

Sterile development lab

Injectables, emulsions and suspensions under controlled conditions.

Sterile formats from simple aqueous injections to nano-emulsions and lyophilised products are developed here, which is why complex parenterals do not have to be sent elsewhere mid-programme.

  • Manufacturing tanks, SS 316L (5–10 L)
  • High-pressure and high-speed homogenisers
  • Filtration tank and peristaltic pump
  • Autoclave
  • Laminar airflow unit
  • Sealer and de-sealer
  • Top-mounted stirrer; magnetic stirrer with heating
  • Microscope, up to 100× magnification
  • pH meter

03

Ointment / topical semisolid development lab

A dedicated Topical Semisolid Development Laboratory for the development and optimization of ointments, creams, gels, lotions and other dermatological formulations.

The facility supports pre-formulation, API–excipient compatibility, vehicle and base selection, formulation screening, homogenization, emulsification and process optimization. Development activities include optimization of critical formulation and process parameters, rheological and physical characterization, drug-content uniformity, in-vitro release testing (IVRT), stability studies and scale-up support. The laboratory is designed to support development of both conventional and complex topical formulations for generic and differentiated products.

  • Vehicle and base selection
  • Homogenization and emulsification
  • Rheological characterization
  • In-vitro release testing (IVRT)

04

Liquid oral development lab

A dedicated Oral Liquid Development Laboratory for formulation and process development of oral solutions, suspensions, emulsions, syrups and other liquid oral dosage forms.

The facility supports pre-formulation, solubility and compatibility studies, vehicle and excipient selection, pH and viscosity optimization, taste-masking, preservative-system development and formulation screening. It enables optimization of critical formulation and process parameters, including mixing, homogenization, suspension characteristics and physical stability. The laboratory also supports analytical evaluation, dissolution/release assessment where applicable, stability studies and scale-up for clinical, BE and commercial batches.

  • Solubility and compatibility studies
  • pH and viscosity optimization
  • Taste-masking
  • Preservative-system development

05

Analytical laboratory

Separation, mass spectrometry, elemental analysis and stability.

Impurities, residual solvents and elemental impurities are identified in the same building as the batch that produced them, so an analytical finding reaches the formulator the same week.

  • Liquid chromatography–tandem mass spectrometry (LC-MS/MS)
  • Gas chromatography–mass spectrometry (GC-MS)
  • Inductively coupled plasma mass spectrometry (ICP-MS)
  • Shimadzu HPLC with UV
  • Dionex ion chromatography
  • Dissolution apparatus, USP I, II and III (Electrolab), with autosampler
  • Franz diffusion apparatus
  • Temperature/humidity-controlled stability chambers and photostability chambers
  • UV and UV-visible spectrophotometers
  • Particle-size analyser, micron to nano
  • Karl Fischer titrator, viscometer, conductivity meter
  • Centrifuge, automatic shaker, sonicator

Science & technology

The science behind difficult-to-make products.

Much of our work sits where routine generic development stops: molecules that are unstable, poorly soluble, hard to deliver or demanding to handle.

Reformulations that solve a patient or supply problem.

Oral liquids made from tablets for children, ready-to-use injectables made from lyophilised powders, extended-release and orally disintegrating tablets, all designed on non-infringing routes.

  • Tablet → oral solution or suspension
  • Powder → ready-to-use injection
  • Immediate → extended release
  • Differentiated topicals

Solifenacin succinate, tablets reformulated as an oral suspension and solution for paediatric patients: 6-month stability completed.

From the laboratories

Equipment list and capacities to be confirmed against the current asset register.V-24

Ways to partner

Five ways to engage, one team behind each.

  1. 01

    Three scientists in lab coats reviewing results together

    Dossier development

    We develop the product and the dossier; you file it.

  2. 02

    A stack of white ring binders full of documents

    Dossier compilation

    We turn development data you already hold into a submission-ready dossier.

  3. 03

    Two business partners shaking hands

    Co-development

    We share the development investment and the commercial return through profit sharing.

  4. 04

    Tablets tumbling in a pharmaceutical production machine

    Technology transfer

    We move a developed product into your plant or your chosen CMO.

  5. 05

    A blister pack of capsules beside its printed carton

    Commercial supply

    We supply finished product through a qualified manufacturing network.

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