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Our Finished Formulation R&D Services are tailored to drive the development of innovative pharmaceutical products from Proof of Concept to Commercialization. Our team of experts offers comprehensive support to ensure successful development and launch of your finished formulations."
Services
Pre-formulation Studies
- Physicochemical Characterization
- Drug- Drug compatibility
- Drug Excipient Compatibility
- Solubility & Stability
- Physicochemical characterization of the reference products
- Stress Testing
- Reverse engineering of Reference products
Formulation Development
Formulations
Developing robust formulations for Oral, Injectable & Topical routes.
Prototype Creation
We create prototype formulations for Proof-of-Concept (POC), Stability testing, and Preclinical trials.
Scale-Up & Optimization
We ensure seamlessly transition from lab-scale to commercial production with process optimization.
Post-Marketing Formulation Adjustments
By addressing unexpected Issues with commercial products, ensuring Continuous Improvement, and Regulatory Compliance.
Patient-Centric Solutions
Developing robust formulations for Oral, Injectable & Topical routes.
Special Population Considerations
Tailoring formulations for specific patient groups, such as pediatrics and geriatrics.
Clinical Study Batch Manufacturing & Clinical Study Support
Manufacturing of formulations (Clinical Phase I, II, III) through various CDMOs for Clinical study support.
Dose Selection
Determining optimal dosage strengths based on preclinical and early clinical data through CRO.
BA/BE Studies
Conducting bioavailability and bioequivalence studies to compare different formulations through CRO.
Pharmaceutical Analysis
- Drug Substance Analysis: Identification, quantification, impurity analysis, and stability testing.
- Drug Product Analysis: Comprehensive formulation analysis and in vitro pharmacokinetic studies.
- Stability Studies: Conducting photostability and stability tests to ensure product quality and shelf-life.
- Analytical Method Development: Developing and validating methods for release testing, stability testing, and quality control.
- Packaging Development: Designing packaging solutions that maintain product integrity and support patient compliance.
- Comprehensive Regulatory Guidance: Providing support for Europe MAH, IND, NDA, and ANDA submissions to ensure compliance and successful market entry.
Vibro Shifter
- Make- Bectochem Lodige
- Model- Vibro Shifter 12”
- Capacity-0.5 – 5 Kg
Unimill
- Make- Hanningfield
- Model- M05-U-022
- Interchangeable parts- Sieves 0.45mm, 0.81mm, 0.99mm, 1.57mm, 2.1mm
- Capacity-0.5 – 5 Kg
Multimill
- Make- Bectochem Lodige
- Model- Mini Super Mill
Granulator
- Make- Bectochem Lodige
- Model-RMG-15L
- Interchangeable parts- Bowls
- Capacity- 15L,10L,5L,2L
Roller Compactor
- Make- Kevin Process Technologies
- Model- KRC120×40
- Interchangeable parts- Rollers – single knitted, Straight Knurled, Cross Knurled
- Capacity- 20Kg/hr
Pelletization
- Make- ACG
- Model- GPCG 1.1
- Capacity-
- Top Spray – 1.4L – 4.7 L
- Bottom Spray- 0.4L – 2.4L
Blender
- Make- Bectochem Lodige
- Model- OCB 25LTRS
- Interchangeable parts- 25L,20L,15L,10L,5L,2L
- Capacity- 2L – 25L
Tablet Compression Machine
- Make- Parle Elezabeth
- Model- 1 EP 400 AWC 11D+11B
- Interchangeable parts- B &D tooling
- Capacity- 22 Stations,(11B & 11D)
Tablet Coating Machine
- Make- Ganscoater
- Model- GAC 380/305 EXT./ 275 Combi
- Capacity- 0.8 Kg, 2.5Kg
Blister Packing Machine
- Make- Parle Elizabeth
- Model- EZ Blister P (SEPHA)
Capsule Filling Machine
- Make- Parle Elizabeth
- Capsule Filling machine’s Interchangeable parts from Size 00 to Size 4
- Capacity-
Molten Mass 800- 1500 Caps/Hr Powder 2500-3000 Caps/Hr Pellets 2000-2500 Caps/Hr Tablets 1200-1500 Caps/Hr
Tap Density Apparatus
- Make- Electrolab India
- Model- ETD-1020X (SS)
- Interchangeable parts- USP-I & USP II
- Capacity- 100 ml & 250 ml
Tablet Hardness Tester
- Make- Electrolab India
- Model- EBT-2PRL(SS)
- Capacity-
Size 0-35 mm Force 0-800 N
Tablet Disintegration Tester
- Make- Electrolab India
- Model- EDI-2SA (SS)
- Capacity- 6+6 Testtubes
Friability Tester
- Make- Electrolab India
- Model- EF-2W
Halogen Moisture Analyzer
- Make- Retsch
- Model- HE73
- Capacity- 50-200°c drying temperature.
Autoclave
- Make- Neelam Industries
- Capacity- 100 L
Fuji Paudal Wet Extrusion Granulation
- 15-20 kg/hr Extrusion rate
- Extruder Speed: 42-85 RPM
- Easily converts into a Dome, Radial, or Axial extruder giving various Density of granules
Laboratory Spheronizer
- Marumerizer Model QJ-230T
- Groove Size: 2-8 mm
- Plate speeds: 600-1800 rpm
Capabilities
Oral Solid Dosage Forms
Tablets, capsules, powders, and granules
Injectable Formulations
Solutions and lyophilized products
Topical Formulations
Creams, ointments, gels, and sprays
Liquid Formulations
Solutions, suspensions, and emulsions
Technical Machine Capabilities
Benefits
Accelerated Development
Expedited development timelines to bring your product to the market on fast track.
Enhanced Product Quality
Robust formulations that provide efficacy, safety, and long-term stability.
Regulatory Expertise
Comprehensive support to ensure compliance with global regulatory standards.
Cost-Effective Solutions
Optimized formulations and processes are designed to minimize production costs.