Innovating Next-Generation Therapeutic Formulations with Clinical Precision
At Shikoy Pharma Pharmaceuticals Pvt. Ltd., formulation innovation and therapeutic development are core drivers of our healthcare mission. In strategic collaboration with accredited WHO-GMP & GLP certified formulation units and research partners, we identify, evaluate, and introduce high-bioavailability, stable, and cost-effective pharmaceutical formulations across India.
From molecular pre-formulation characterization to commercial scale-up, our partner scientists, formulation chemists, and analytical specialists work in ultra-modern cleanroom environments to deliver DCGI-compliant, patient-centric drug delivery solutions for our marketing and franchise network.
Core Pillars of Our Formulation Standards
Our accredited manufacturing partner facilities integrate comprehensive chemical, physical, and pharmaceutical testing at every stage of formulation development.
Formulation Development (F&D)
Engineering robust dosage forms including immediate-release tablets, sustained & delayed-release pellets, chewable tablets, hard gelatin capsules, dry syrups, and topical dermatological formulations.
- Taste-masking technology for pediatric syrups
- Enhanced solubility for poorly soluble APIs
- Bilayer & enteric-coated oral solids
Analytical Method Validation
Developing and validating ultra-sensitive, stability-indicating analytical assay methods in accordance with ICH Q2(R1) guidelines, ensuring accuracy, precision, limit of detection, and linearity.
- Reverse-Phase HPLC & UV Spectrophotometry
- Related substances & impurity profiling
- Residual solvent testing (GC-HS)
ICH Stability Chambers
Continuous environmental monitoring with calibrated walk-in and stand-alone stability chambers adhering strictly to Zone IVb tropical climatic zones (India & Southeast Asia).
- Accelerated Testing (40°C ± 2°C / 75% RH)
- Real-Time Long-Term Testing (30°C / 75% RH)
- Photo-stability & thermal stress testing
Dissolution & Bioequivalence
Rigorous multi-point in-vitro dissolution profiling across various physiological pH media to guarantee therapeutic equivalence to originator brands.
- Automated 8-station USP Type I & II testers
- Similarity factor (f2) mathematical validation
- Predictable gastrointestinal absorption curves
Novel Packaging Innovation
Pharmaceutical packaging is engineered to protect sensitive molecules against ambient humidity, photolytic degradation, and thermal fluctuation during transportation and shelf storage.
- Cold-form Alu-Alu high barrier foils
- Moisture & oxygen scavenging blister films
- Child-resistant & senior-friendly cap designs
Pilot Scale-Up & Tech Transfer
Seamless translation of lab-scale formulation recipes into high-volume commercial production with meticulous Critical Process Parameter (CPP) and Critical Quality Attribute (CQA) controls.
- Comprehensive Technology Transfer Dossiers (TTD)
- 3-Consecutive commercial validation batch audits
- Zero batch rejection yield optimization
Advanced Analytical & Testing Instruments
All formulations in our portfolio are manufactured and tested at partner laboratories equipped with 21 CFR Part 11 compliant analytical software and state-of-the-art instruments calibrated regularly with traceable international standards.
High-speed autosamplers with PDA detectors.
Spectral scanning from 190nm to 1100nm.
8-vessel automated apparatus with autosampler.
Volumetric moisture determination in tablets.
Targeted Therapeutic Formulation Pipeline
Our scientific pipeline focuses on therapeutic segments with high clinical demand, introducing bioavailable and synergistic combinations.
Anti-Infectives & Antibiotics
Broad-spectrum Cephalosporins, Macrolides, Quinolones, and Beta-Lactam + Clavulanate synergies.
Gastroenterology
PPIs with prokinetics, anti-ulcerants, digestive enzymes, and antacid oral suspensions.
Pain Management & Ortho
NSAIDs with muscle relaxants, serratiopeptidase combinations, and joint supplements.
Respiratory & Derma
Mucolytics, bronchodilators, anti-allergic syrups, and topical antimicrobial derma lotions.