What we do
We provide services such as early phase formulation development, Preformulation & Drug product characterization studies and testing, stability studies and Life Cycle Management. We provide development services ranging from Complex Generics, Niche Generics, NCE formulation, Reformulations and Life Cycle Management& 505(b)2 submissions. Our expertise in development of analytical methods caters complete development demand. We also provide customized solutions for analytical method development. Beyond the manufacturing and analytical solutions, we prioritize the release and stability evaluation of the drug products. Our testing methodologies include Accelerated stability studies and ICH stability testing.
Our state-of-the-art R&D facility is well equipped to carry out formulation development activities on Oral solid, oral liquid and semisolid dosage forms located in Hyderabad. Our service categories includes
By implementing a QbD strategy, a better scientific understanding is obtained and unnecessary testing is eliminated, reducing the cost and increasing the overall speed of the development process.
- To ensure desired drug product quality, safety and efficacy, a Quality Target Product Profile (QTPP) is defined prior to formulation development
- The Critical Quality Attributes (CQA) of the drug product are determined
- A risk assessment is conducted to evaluate the impact of raw material attributes and process parameters on the CQA
- A design space is established describing the relation between the input (raw material attributes and process parameters) and the end product quality.
These evaluations ensure that the manufactured drug products meet the required quality standards and remain stable throughout their shelf life.
Our Formulation Services Includes
Preformulation studies
- Solubility Studies
- Drug excipient compatibility studies
- Intrinsic dissolution
- Drug product characterization studies
- Analytical Method Development
- Accelerated and stress stability studies under different conditions
- Forced degradation studies including photo stability
- Solubility Studies
- Drug excipient compatibility studies
- Intrinsic dissolution
- Drug product characterization studies
- Analytical Method Development
- Accelerated and stress stability studies under different conditions
- Forced degradation studies including photo stability
Dosage forms
- Tablets: Immediate-release, Sustained/ Controlled -release, Delayed-release, Film-coated
- Layered tablet
- Sublingual
- Orally disintegrating tablets
- Capsules: filling powder or granules
- Pellets: Filled into tablets or capsules
- Powders: Powder in a bottle,
- Liquids: Solutions, Suspensions, Emulsions
- Semi-solids: Creams, Ointments, Gels, Lotions
- Tablets: Immediate-release, Sustained/ Controlled -release, Delayed-release, Film-coated
- Layered tablet
- Sublingual
- Orally disintegrating tablets
- Capsules: filling powder or granules
- Pellets: Filled into tablets or capsules
- Powders: Powder in a bottle,
- Liquids: Solutions, Suspensions, Emulsions
- Semi-solids: Creams, Ointments, Gels, Lotions
OUR EXPERTISE
We have a well-established formulation development lab to carry out formulation development activities as below
Formulation technologies
- Dry blendshear granulation
- Fluid bed granulation
- Roller compaction
- Wurster coating
- Perforated Pan Tablet Coating
- Encapsulation (Pellets, powder and granules)
- MUPS
- Taste-Masking
- Tablet Press
- Capsule Filling (Powder, Granules, Pellets)
- Blister packaging
- HDPE bottle packaging capability
- Dry blendshear granulation
- Fluid bed granulation
- Roller compaction
- Wurster coating
- Perforated Pan Tablet Coating
- Encapsulation (Pellets, powder and granules)
- MUPS
- Taste-Masking
- Tablet Press
- Capsule Filling (Powder, Granules, Pellets)
- Blister packaging
- HDPE bottle packaging capability
Formulation development Specialties
- Complex Generics
- Niche Generics
- NCE formulation
- Life Cycle Management
- 505(b)2 submissions
- Complex Generics
- Niche Generics
- NCE formulation
- Life Cycle Management
- 505(b)2 submissions
Formulation Equipment’s list
| Equipment Name | Model | Manufacturer |
| High Shear Mixer Granulator | HSMG-10 | Kevin |
| Fluid bed Processor | GPCG 1.1 | Pam Glatt |
| Lab Ultra Mixer-10 | PULM-10 | Prism Pharma Machinery |
| 8 Granulator (Oscillating Granulator) | CMJ-8 | Cadmach |
| Rapid Dryer | TG 200 | Restch |
| Octagonal Blender | MB30 | Anchor Mark |
| Roller Compactor | KMRC 05 | Kevin |
| Quadro comill | 197 | Quadro |
| Drive unit for multiple mixers | MDB | Anchor Mark |
| Tabletting Machine (Single Rotary, 8-Station) | KMPC-08 | Cadmach |
| Tabletting Machine (Single Rotary double layered, 9 Station) | EP-200L (9D) | Parle Eliza |
| Tablet Coating System | SC-18 | Kevin |
| Automatic coating Machine | NEOCOTA 5M | Neo coata |
| Induction Sealing Machine | CSP-300 | Electronic Devices |
| Blister Packing Machine | Ezee Blist-P | Mechtek |
| Capsule Filling Machine(Manual) | MF 30 D | Pam Pharma |
Analytical Equipment’s / Instruments list
| Equipment Name | Model | Manufacturer |
| Fourier Transform Infra red spectrometer System | IR Affinity_1 | Shimadzu |
| UV-VIS Spectrophotometer | UV-2450 | Shimadzu |
| KF Titrator | KF-809 Titrindo | Metrohm |
| Magnetic stirrer with heating | RH D.KT/C | Ika |
| Compact Shaker(Cyclo mixer) | MS 3 DIGITAl | Ika |
| Vortex Shaker(Cyclo mixer) | GENIUS 3 | Ika |
| Water Bath | BIO | Biotechnics India |
| Humidity Chamber(25/90) | NEC216R10S1 | Newtronic |
| Hot Air Oven | Bio | Biotechnics India |
| Ultra Performance Liquid chromatography | Acquity | Waters |
| Orbital Shaker incubator | OSI-264 | NEOLAB |
| Magnetic stirrer | Lab disc | IkA |
| Magnetic stirrer with heating | C MAG HS 10 | IkA |
| Multi position magnetic stirrer | RT10 POWER | IkA |
| Dissolution Test Apparatus | DS 8000 SC/TR | Labindia |
| Ultra Micro Balance | SE2 | Sartorius |
| Millipore water purification system | ELIX-10 | Millipore |
| Sonicator | CPX8800H-E | Branson |
| Flow meter | 1000-Series | Agilent |
| Vacuum oven | BTI-51 | Biotechnics India |
| pH Meter | UYI-17357 | ThermoScientific |
| Centrifuge | LABHC-103 | LABOCON |
| Millipore water purification system | Advantage A10 | Millipore |
| Digital Thermometer (For refrigerator) | TM-803 | Kasturi Industries |
| YC-260 WDFI Medical Refrigerator | YC-260 WDFI | BLUESTAR |
| High Performance Liquid Chromatography | ACQ-rFTN | Waters |
| High Performance Liquid Chromatography | LC-2050C 3D | SHIMADZU |
| Hard top chest freezer | CHF500HGW | Blue Star |