KP Pharmaceutical
Contract research organization (CRO) and contract manufacturing organization (CMO) founded in 1997 in Bloomington, IN. Operates a ~60,000 sq.ft cGMP facility with independent QC laboratory and ISO-5/class 100 clean rooms for sterile manufacturing. Provides end-to-end services from preformulation and formulation development through analytical testing, clinical trial material manufacturing and commercial supply, with regulatory support for CMC/IND/ANDA/NDA submissions.
Industries
Nr. of Employees
small (1-50)
KP Pharmaceutical
Products
Formulation Development
Development of drug formulations from preclinical stages to commercial manufacturing under cGMP conditions.
Clinical Manufacturing & Packaging
Manufacturing and packaging of clinical trial materials under cGMP standards for use in clinical studies.
Commercial Manufacturing & Packaging
Large-scale production and packaging of pharmaceutical products for commercial distribution under cGMP compliance.
Aseptic Fill and Finish
Sterile filling and finishing of pharmaceutical products to maintain product sterility and quality.
Lyophilization
Freeze-drying process to stabilize pharmaceutical products for extended shelf life and storage.
Microfluidization
A process to reduce particle size and improve uniformity in pharmaceutical formulations.
Formulation Development
Development of drug formulations from preclinical stages to commercial manufacturing under cGMP conditions.
Clinical Manufacturing & Packaging
Manufacturing and packaging of clinical trial materials under cGMP standards for use in clinical studies.
Commercial Manufacturing & Packaging
Large-scale production and packaging of pharmaceutical products for commercial distribution under cGMP compliance.
Aseptic Fill and Finish
Sterile filling and finishing of pharmaceutical products to maintain product sterility and quality.
Lyophilization
Freeze-drying process to stabilize pharmaceutical products for extended shelf life and storage.
Microfluidization
A process to reduce particle size and improve uniformity in pharmaceutical formulations.
Services
Characterization of APIs and excipients (pH-solubility, stability profiling, particle size effects, compatibility) to inform formulation and development strategy.
Development and optimization of solid, topical and parenteral dosage forms, including controlled-release, microemulsion, microsphere and liposome systems with validated analytical methods and process documentation for scale-up.
Analytical method development, validation, stability-indicating testing and shelf-life assessment under ICH/FDA guidelines; contract testing under cGMP/cGLP.
Manufacture and packaging of clinical supplies (placebo, over-encapsulation, double-blind kits), labeling, customized blister cards, storage and distribution/repository services.
Commercial-scale production, packaging and release testing of drug products with in-house QC and documentation to support market supply.
Compilation and preparation of CMC content for IND, NDA and ANDA submissions and regulatory assistance related to manufacturing and quality systems.
Characterization of APIs and excipients (pH-solubility, stability profiling, particle size effects, compatibility) to inform formulation and development strategy.
Development and optimization of solid, topical and parenteral dosage forms, including controlled-release, microemulsion, microsphere and liposome systems with validated analytical methods and process documentation for scale-up.
Analytical method development, validation, stability-indicating testing and shelf-life assessment under ICH/FDA guidelines; contract testing under cGMP/cGLP.
Manufacture and packaging of clinical supplies (placebo, over-encapsulation, double-blind kits), labeling, customized blister cards, storage and distribution/repository services.
Commercial-scale production, packaging and release testing of drug products with in-house QC and documentation to support market supply.
Compilation and preparation of CMC content for IND, NDA and ANDA submissions and regulatory assistance related to manufacturing and quality systems.
Expertise Areas
- cGMP manufacturing
- Formulation development (solid, topical, parenteral)
- Preformulation and material characterization
- Analytical method development and validation
Key Technologies
- Aseptic fill-finish (ISO-5/class 100)
- Lyophilization
- Controlled-release formulation technologies
- Microencapsulation / microspheres
News & Updates
Site post highlighting the company's positioning as a full-service CRO/CMO since 1997.
Site post highlighting the company's positioning as a full-service CRO/CMO since 1997.