Formulation Development

Pharmafabrikon FD, initiates each drug development program with major consideration for implementing the most effective regulatory strategy to cost-effectively to achieve near and long-term goals. FD believe potential issues addressed early will accelerate overall development time.

FD offers customers a fully integrated and seamless dosage form development program generally includes API characterization, pre-formulation studies, excipient- compatibility studies, product-pack integrity studies, analytical methods development and validation, composition and process optimization, stability studies, scale-up and process validation.

FD develops a wide range of pharmaceutical, nutraceuticals, dietary supplements and veterinary products such as orals (Tablets, Capsules, Liquids, Dry syrups and Powders), sterile (injectiables). Our product range covers large and diverse therapeutic segments and caters to several regions.

FD have well equipped process equipments to conduct lab trials and scale-up batches.

Well competent team capable to develop and transfer the product as per global regulatory norms.

Analytical Development

Analytical development offers stand alone services and supports our formulation development activities. The AD teams are integrated with formulation development teams to ensure effective and accelerated product development.

• Analytical method development for finished products.
• Analytical method validation for finished products.
• Analytical method validation for APIs.
• Analytical method transfer.
• Analytical method verification.
• Cleaning method development and validation.
• Evaluation of elemental impurities as per ICH guidelines.
• Development stability studies as per ICH guidelines.
• Pre-formulation studies.
• Preparation of working standards.
• Intrinsic dissolution.