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)

Preformulation

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

Capabilities:

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

Microbiology

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.

Services

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

Equipment’s

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: