Dosage form development

Our formulation laboratories are fully equipped for development of any product from NCEs to generics including specialty products and oncology product development. We also specialize in reformulation and life cycle extension of existing molecules. We develop effective and efficient products within the committed timelines by utilizing process analytical technologies (PAT)


Our dedicated team of scientists have their core training in the area of preformulation and have expertise in the complete pharmaceutical profiling of molecules
Preformulation Services:
  • Polymorph screening and selection
  • Salt form selection
  • Crystalline properties
  • pH solubility and stability
  • Solid-state and solution-state stability
  • Photostability
  • pKa and partition coefficient determination
  • Hygroscopicity
  • Morphology assessment
  • Solubility studies
  • Intrinsic dissolution
  • Excipient compatibility
  • Leachables and Extractables studies
  • Flowability
  • Particle size determination by laser lights
  • Container – active pharmaceutical ingredient (API) interactions
  • Thermal analysis: DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analyzer)
  • Dynamic Vapor sorption/desorption
  • pXRD (X-Ray Diffraction)
  • FT-IR (A Fourier Transform Infrared) spectrometer Capillary Electrophoresis
  • SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscope)
  • Potentiometer
  • Hot-stage Microscopy
  • Laser light diffraction Particle size analyzer
  • Intrinsic dissolution
  • Head Space GC analyzer
  • ICPMS (Inductively Coupled Plasma Mass Spectrometry)
  • IC (Ion Chromatography)
  • Zeta sizer
  • Malvern particle size analyzer
  • AAS (Atomic Absorption Spectroscopy)

Formulation development

Our scientists use Quality-By-Design (QbD) tools at all stages of formulation development. Design of experiments (DOE) along with risk assessment strategies allows us to design our experimental plan. Our development approach allows us to meet our delivery timelines and helps us in providing our clients with cost-effective drug delivery solutions
Dosage forms
  • Tablets : Immediate-release, Sustained-release, Delayed-release, Film-coated, Layered tablet
  • Capsules : Powder, Granule filling
  • Parenteral- Solutions, Suspensions, Emulsions, infusions
  • Ophthalmic- Solutions, Suspensions, Emulsions
  • Pellets : Into tablets or Capsule filled
  • Powders : Powder in a bottle, Powder for Injection
  • Liquids : Solutions, Suspensions, Emulsions
  • Semi-solids : Creams, Ointments, Gels, Lotions
Formulation technologies
  • Dry blending
  • High shear granulation
  • Fluid bed granulation
  • Roller compaction
  • Extrusion spheronisation
  • Wurster coating
  • Spray drying
  • Micronization
  • Pan Coating
  • Encapsulation
  • Injectable lyophilisation
  • Injectable depot formulation
Formulation development Specialties
  • Generic products
  • First Generic products
  • Complex Generics
  • Niche Generics
  • NCE formulation
  • Life Cycle Management projects
  • 505(b)2 submissions
  • Enabling formulations and Late stage clinical formulations
Equipment And Process Capabilities
  • Direct Tablet Compression
  • Fluid Bed Processing (Granulation, Drying, Coating)
  • High Shear Wet Granulation
  • Dry Granulation (Roller Compaction, Slugging)
  • Extrusion Spheronization
  • Perforated Pan Tablet Coating
  • Automated Capsule Filling (Powder, Granules, Pellets)
  • Spray Drying
  • Microencapsulation
  • Low Humidity / Moisture Requirements
  • Taste-Masking
  • High Potency Compound Handling
  • Instrumented Tablet Press
  • Lyophilizer

Analytical research and Development

Analytical research and development (AR&D) offers standalone services and supports our formulation development activities. The AR&D teams are integrated with preformulation, product development and quality assurance teams to ensure effective and accelerated product development. Our experience in developing methods for highly complex and unstable drug products compliments our formulation capabilities
Analytical services
  • Method development
  • Method validation
  • Method qualification
  • Method transfers
  • Stability studies including zone IV studies
  • Chiral analysis
  • Microscopy

We offer a wide range of compendial and non-compendial testing services. Our microbiology laboratories are designed to facilitate in-house studies as well standalone testing services for our clients.

  • Microbial Limit test
  • Antimicrobial Efficacy test
  • Environmental Monitoring
  • Water chemical and microbial analysis
  • Bacterial endotoxin test
  • Antibiotics and vitamins assays
  • Raw materials/excipients analysis as per BAM (Bacteriological Analytical Manual)
  • Disinfectants analysis
  • HPLCs with photodiode array detectors
  • Head space GC analyzer
  • FT-IR (A Fourier Transform Infrared) spectrometer
  • NMR (Nuclear Magnetic Resonance)
  • pXRD (X-Ray Diffraction)
  • Thermal analysis: DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analyzer)
  • Dynamic vapor sorption/desorption
  • Capillary electrophoresis
  • SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscope)
  • Potentiometer
  • Laser light diffraction particle size analyzer
  • Dissolution apparatus
  • AAS (Atomic Absorption Spectroscopy)
  • ICPMS (Inductively Coupled Plasma Mass Spectrometry)
  • IC (Ion Chromatography)

Clinical Services

BA/BE Studies

  • State-of-the-art facilities with global access to 160+ beds
  • Tie up with multispecialty hospital to perform specific studies
  • Excellent scientific expertise with capabilities of handling challenging studies
  • Robust recruitment & housing options customizable to sponsor / study requirements
  • Independent ethics committee/ Institutional Review Board
  • Offsite storage of data for disaster recovery and business continuity
  • Experience of Proof of concept studies, Patient PK Studies, Food Interaction Studies, Clinical end point studies and Clinical Trials
  • Volunteer database
Male: 8000+
Female: 2000+
Access to post-menopausal women database

Bio analytical Services

Our Bioanalytical laboratory is equipped with state-of-the art Liquid Chromatography and Tandem Mass Spectrometry (LC-MS/MS) instruments with a capacity of 4000 samples per week. Our highly qualified team of scientists with in-depth knowledge in instrumentation and application of LC-MS/MS technology enables timely method development. We validate our analytical methods as per global regulatory requirements and we follow applicable GLP guidelines.
Our scientists have derived a process flow that generates results with quality withstanding any regulatory scrutiny while meeting your timelines. With a proven track record in developing methods for highly complex (hormones) and unstable molecules, we are your right partner for all your bioanalytical needs.
We currently perform bioanalysis on the following LC-MS/MS:
  • Shimadzu UFLC – API 4000 Sciex
  • Waters Alliance – Quattro premier XE
  • Agilent Infinity UHPLC – Agilent 6460
  • Instruments to be updated

Contract Manufacturing Services

Commercial Manufacturing services

Manufacturing Technologies
  • Wet Granulation (High Shear and Top spray)
  • Dry Granulation
  • Roller Compaction
  • Direct compression
  • Bilayer Tablet compression
  • Encapsulation (Pellets, powder and granules)
  • MUPS
  • Pelletization (Extrusion-Spheronization, Wurster-Processer)
  • Unit Dose Packaging(Blisters/Strips, bottles)
  • Bottle and Blister packaging lines
Manufacturing Services
  • Low volume commercial supplies
  • Exhibit
  • Scale up and
  • Clinical batch manufacturing

International Accreditations

cGMP Clinical Supplies

  • Phase I to Phase IV Clinical Trials Support
  • Primary and secondary packaging and labeling
  • Quality release
  • Warehouse and distribution
  • Project management
  • Coordination of transportation
  • Sourcing drugs
  • Ancillary supplies