CMC Pharmaceuticals, Inc.
CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. They specialize in formulation development, analytical chemistry, cGMP lab services, stability evaluations, and more, supporting clients from early development through commercialization. Their mission is to help develop new and better drug formulations, ensuring quality, safety, and efficacy, and to accelerate drug development timelines.
Industries
Nr. of Employees
small (1-50)
CMC Pharmaceuticals, Inc.
Services
Pre‑formulation, formulation design and optimization for oral, injectable and complex dosage forms with prototype preparation to support in vitro and in vivo studies.
Development, optimization and validation of analytical methods (U/HPLC, LC‑MS, UV, dissolution, Karl Fischer, osmolarity) and execution of routine testing to produce regulatory‑ready data.
cGMP‑compliant analytical testing including release testing, GMP stability studies, compatibility testing and generation of documentation suitable for regulatory filings.
Design and execution of ICH and custom stability programs, container‑closure and compatibility studies, in‑use and accelerated testing to determine shelf life and storage conditions.
Design and formulation of long‑acting and controlled‑release systems including biodegradable polymer depots, non‑degradable implants and in‑situ forming systems.
Small‑scale pilot production of prototypes (tablets, capsules, injectables, long‑acting formulations) and preparation of pilot batches to support testing and early clinical studies.
Pre‑formulation, formulation design and optimization for oral, injectable and complex dosage forms with prototype preparation to support in vitro and in vivo studies.
Development, optimization and validation of analytical methods (U/HPLC, LC‑MS, UV, dissolution, Karl Fischer, osmolarity) and execution of routine testing to produce regulatory‑ready data.
cGMP‑compliant analytical testing including release testing, GMP stability studies, compatibility testing and generation of documentation suitable for regulatory filings.
Design and execution of ICH and custom stability programs, container‑closure and compatibility studies, in‑use and accelerated testing to determine shelf life and storage conditions.
Design and formulation of long‑acting and controlled‑release systems including biodegradable polymer depots, non‑degradable implants and in‑situ forming systems.
Small‑scale pilot production of prototypes (tablets, capsules, injectables, long‑acting formulations) and preparation of pilot batches to support testing and early clinical studies.
Expertise Areas
- Formulation development for small molecules and complex dosage forms
- Analytical method development and ICH/cGMP method validation
- cGMP laboratory testing and regulatory‑usable data generation
- Stability program design (ICH and custom) and expiry dating
Key Technologies
- Ultra/high‑performance liquid chromatography (U/HPLC)
- Liquid chromatography–mass spectrometry (LC‑MS)
- USP dissolution apparatus (Apparatus II and IV) and in vitro release systems
- Karl Fischer moisture titration
News & Updates
Development of a stable, fixed-dose combination of atropine and scopolamine for nerve agent countermeasures, supported by a DoD SBIR grant.
Program to extend shelf-life of a prophylactic medical countermeasure, from 3 to 14 months, supported by cGMP stability studies and FDA submission.
Development of improved nerve agent countermeasures in collaboration with Battelle and the DoD.
Guidance on selecting a development partner to accelerate drug development timelines and ensure regulatory compliance.
CMC Pharma's recent FDA unannounced inspection resulted in no objectionable conditions, supporting their cGMP lab services.
Overview of stability studies' role in drug development, shelf-life determination, and regulatory compliance.
Development of a stable, fixed-dose combination of atropine and scopolamine for nerve agent countermeasures, supported by a DoD SBIR grant.
Program to extend shelf-life of a prophylactic medical countermeasure, from 3 to 14 months, supported by cGMP stability studies and FDA submission.
Development of improved nerve agent countermeasures in collaboration with Battelle and the DoD.
Guidance on selecting a development partner to accelerate drug development timelines and ensure regulatory compliance.
CMC Pharma's recent FDA unannounced inspection resulted in no objectionable conditions, supporting their cGMP lab services.
Overview of stability studies' role in drug development, shelf-life determination, and regulatory compliance.