Cuckos's
DRUG PRODUCT
Development
Team of experienced professionals having over 20 years’ experience, We can help clients shape their product offerings by continually innovating and developing new technologies and processes. So it’s fair to say, we know what we’re doing. We are ideally placed to deliver a wide range of GMP-compliant services from our dedicated development facilities, each designed to adapt to customer needs.
Complementing our manufacturing services, we can give you access to a wealth of process development and production expertise. This means we always have the bigger picture in mind when developing your product.
Formulation Development
Humans & Animal Health
Our formulation laboratories are fully equipped for the development of any product from NCEs to generics including specialty products for human as well as Animal 4 health. 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 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
Injection : Solution for injection, Powder for injection, Suspension for injection, Non aqueous liquid
solution
Capsules : Powder, Granule filling
Pellets : Into tablets or Capsule filled
Powders : Powder in a bottle
Liquids : Solutions, Suspensions, Emulsions
Semi-solids : Creams, Ointments, Gels, Lotions
Animal health: Spot on, pour on, soft chewable platform, hard chewable flavoured tablets etc.
Analytical Method
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.
Method Development & Validation
We offer a wide range of compendial and non-compendial testing services. Our analytical laboratories are based on philosophy of cGLP and designed to facilitate in-house development and validation of API as well as drug product methods like assay, dissolution, residual solvent, related substances etc.
Project
Management
At Cuckos, project management is all about delivering to plan, in time, within budget and with right sized communication. Our project managers are experienced in managing complex projects, working with geographically distributed resources, suppliers, vendors and contractors with a pulse on execution.
Cuckos has the right resources available to deal with each project and its uncertainties.
Our key differentiators are:
• Experienced project managers with knowledge of Six Sigma processes
• Metrics based project planning and execution
• Single point of contact for accountability
• Supported by a multifunctional team
• Nimble change control process
Standalone
Services
Most of our standalone services are drive by ICH/VICH complaint protocols and reports.
Stability studies:
Cuckos offers GLP compliant ICH stability testing services to support your changes in marketed formulation.
Analytical Method Development/Validation:
Cuckos offers GLP compliant ICH method development and Validation services to support your dossier requirement as well as any change in marketed formulation.
Routine Analysis:
Cuckos offers GLP compliant routine testing services to check your product quality by generating certificate of analysis which include testing parameters like description, Identification, Assay, Dissolution, Related substances, water by KF etc.
Trouble Shooting:
As we have experienced formulation and technology transfer person so if you are facing any challenge in your product manufacturing, we can provide you the solution for robust and continuous manufacturing.
Technology Transfer:
We have developed a lot of inhouse products where we can do the direct technology transfer to the client manufacturing sites in emerging markets.
Research Activities
Formulation development for early safety studies
Prototype formulations for clinical trials
Prototype formulation screening studies
Formulation / process optimization
Preliminary process identification
Commercial formulation development for NME’s, ANDA’s and OTC’s
Process development optimization
Scale up / technology transfer
Liposomal drug delivery technology
Soft chewable tablets for companion animals
Transdermal delivery system
Analytical Activities:
API Characterization
Method development, validation and transfer
Stability studies
Photo stability studies
Analytical methods for cleaning verification and validation
Analytical Activities
API Characterization
Method development, validation and transfer
Stability studies
Photo stability studies
Analytical methods for cleaning verification and validation
Dissolution and drug release profiling
Forced degradation studies and stability indicating method development
Specifications development
Regulatory support
Stability Testing
Cuckos offers GLP compliant ICH stability testing services. We have dedicated stability chambers for informal (R&D) and registration (cGMP) stability.
All our walk-in stability chambers are continuously monitored.
We use 21 CFR Part 11 compliant software. An alert system, back up chamber and electricity back-up assures sample integrity. The following climatic zones are available: 5°C, 25°C/60% RH, 30°C/65% RH, 30°C/35% RH, 40°C/75% RH,
Photo stability chamber
Customer specific conditions
Facilities
About 6,000 sq. ft. of laboratory space is dedicated to product development with state-of-the art
infrastructure. We have dedicated areas for R&D with additional facilities to handle non-potent and potent molecules.
Equipment & 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
• Formulation Equipment List
• Rapid Mixer
• Roll compactor
• Fluid Bed drier
• Fluid bed processor
• Spray Drier
• Blender
• Planetary mixer
• Compression machine
• Soft Chew machine
• Coating machine
• Hardness Tester
• Disintegrating Test apparatus
• Friability tester
• Capsule filling machine
Injectable Equipment List
• Autoclave
• Homogenizer
• Mechanical stirrer
• Filtration Assembly
• Laminar Air Flow
• Dosing Pump
• Magnetic Stirrer with Hot Plate
• Lyophilizer
• Hot Air Oven SS
• Low humidity / moisture requirements
• Taste-masking
• High potency compound handling
• Formulation Equipment List
• Rapid Mixer
Analytical Instruments List
• HPLCs with photodiode array detectors
• Head space GC analyser
• FT-IR (A Fourier Transform Infrared) spectrometer
• Thermal analysis: DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analyzer)
• Dynamic vapor sorption/desorption
• Capillary electrophoresis
• Potentiometer
• Laser light diffraction particle size analyser
• Intrinsic dissolution
• Dissolution apparatus
