Solid Dosage Development & Manufacturing Services
Advanced Formulation, Scalable Manufacturing & Regulatory Excellence
At GJC Pharmaceuticals Pvt. Ltd., we provide end-to-end solid oral dosage development services, supporting pharmaceutical companies from early-stage formulation to commercial-scale manufacturing. With a strong foundation in Quality by Design (QbD) and Design of Experiments (DoE), we ensure scientifically optimized, robust, and regulatory-compliant formulations aligned with NDA/ANDA filing requirements.
Our goal is to deliver deep product understanding, ensuring consistent quality, manufacturability, and long-term stability.
Comprehensive Solid Dosage Development Capabilities
Formulation Development & Optimization
We specialize in the development of high-performance solid oral dosage forms, including tablets, capsules, and granules. Using QbD principles, we systematically optimize formulations for:
1. Enhanced bioavailability 2. Process robustness 3. Regulatory compliance 4. Cost-effective scalability
Chemical & Analytical Characterization
Our advanced analytical capabilities ensure complete understanding of dosage forms:
1. Impurity profiling and degradation pathways 2. Stability studies (ICH guidelines compliant) 3. Excipient compatibility studies 4. API characterization and interaction analysis
Physical Characterization of Solid Dosage Forms
We evaluate critical material attributes to ensure smooth manufacturing processes:
1. Particle size distribution 2. Bulk and tapped density 3. Flowability and compressibility 4. Powder behavior for downstream processing
Tablet Development & Evaluation
We develop a wide range of tablet formulations tailored to therapeutic needs:
1. Immediate-release and sustained-release tablets 2. Enteric-coated formulations 3. Multi-strength dosage development
Evaluation Parameters Include:
1. Hardness and friability 2. Dissolution profiling 3. Content uniformity and stability
Solubility Enhancement Technologies
For poorly soluble APIs, we offer advanced formulation solutions:
1. Spray drying technology 2. Micronization techniques 3.Bioavailability enhancement strategies
Clinical to Commercial Manufacturing
GJC supports flexible manufacturing scales, ensuring seamless transition across all development stages: 1. Early-phase clinical trial supplies 2. Scale-up for Phase II & III trials 3. Commercial-scale manufacturing
We also provide: 1. Process validation support 2. Technology transfer expertise 3. Regulatory documentation assistance
Production & Manufacturing Capabilities
Our WHO-GMP compliant facilities are equipped with advanced technologies for efficient and scalable production: