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Capability

cGMP compliance

Suppliers
2
States & provinces
2
Countries
1

2 cgmp compliance suppliers across 2 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

AMERICAN INJECTABLES INC

BROOKSVILLE, FL

American Injectables is an FDA-approved, U.S.-based CDMO that manufactures sterile injectables with quality, speed, and consistency. It provides integrated sterile injectable development, fill-finish, packaging, testing, and commercial manufacturing services, combining modern infrastructure and seamless operations from early development through commercial supply.

analytical and microbiology labsaseptic fill-finishmanufacturingpackagingprocess engineeringquality assurancequality controlreal-time environmental monitoringsyringe fill-finishvial fill-finishwarehouse storage

Compiled from public sources

CMC PHARMACEUTICALS INC

SOLON, OH

CMC Pharma is a small molecule contract development and manufacturing organization (CDMO) providing end-to-end CMC (Chemistry, Manufacturing, and Controls) drug development services. It offers formulation and process development, analytical chemistry, ICH stability and compatibility testing, method transfer, scale-up and tech transfer, CMO selection and oversight, and integrated regulatory support for IND/NDA submissions. The company operates cGMP laboratories and a pilot plant for non-GMP small batch production but does not own a commercial GMP manufact

analytical method development and validationCMO management and oversightcompatibility assessmentsdissolution studiesforced degradation studiesformulation developmentICH stability testingmethod transferpilot plant small batch productionprocess developmentregulatory submission supportrelease testingScale uptech transfer

Compiled from public sources

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