Norac Pharma
Norac Pharma is a California-based API contract research and manufacturing organization dedicated to process development, analytical services, and cGMP manufacture of Active Pharmaceutical Ingredients (API) and intermediates. With over 50 years of API experience, including expertise in Controlled Substances and Potent Compounds, Norac Pharma offers timely, efficient, and regulatory-compliant services to support API development. The company emphasizes excellence in process R&D, manufacturing, and regulatory support, aiming to be the contractor of choice for process R&D and API supply. It serves a broad portfolio of clients from small biotechs to large pharmaceutical companies across the USA, providing personalized service, innovative process design, and high-quality standards.
Industries
Nr. of Employees
medium (51-250)
Norac Pharma
Azusa, California, United States, North America
Patents
Products
Contract API Manufacturing and Process R&D Services
Norac Pharma provides contract active pharmaceutical ingredient (API) manufacturing, process R&D, chemical literature review, analytical method development and validation, and cGMP manufacture for clinical trials and commercial products.
Process Research and Development
Comprehensive process research and development services to establish the best synthesis and production process for customer needs, supported by expert GMP-enabled analytical development scientists and comprehensive analytical tools.
Analytical Research & Development
Comprehensive analytical research and development services supporting all phases of API and drug product development, method validation, stability testing, and quality control.
Kilo Lab
Norac Pharma’s state-of-the-art R&D Scale-Up Facility is cGMP compliant and equipped to produce kilogram quantities of API for toxicological, preclinical, and Phase I through III clinical trials.
cGMP Manufacturing and Pilot Plant Facilities
Multi-purpose cGMP facilities featuring computerized process control, glass line reactors, filter dryers, and liquid isolation capabilities.
Preclinical Manufacturing
Norac Pharma provides preclinical API, starting materials, and intermediates manufacturing services ranging from laboratory scale to large-scale preclinical production.
Contract API Manufacturing and Process R&D Services
Norac Pharma provides contract active pharmaceutical ingredient (API) manufacturing, process R&D, chemical literature review, analytical method development and validation, and cGMP manufacture for clinical trials and commercial products.
Process Research and Development
Comprehensive process research and development services to establish the best synthesis and production process for customer needs, supported by expert GMP-enabled analytical development scientists and comprehensive analytical tools.
Analytical Research & Development
Comprehensive analytical research and development services supporting all phases of API and drug product development, method validation, stability testing, and quality control.
Kilo Lab
Norac Pharma’s state-of-the-art R&D Scale-Up Facility is cGMP compliant and equipped to produce kilogram quantities of API for toxicological, preclinical, and Phase I through III clinical trials.
cGMP Manufacturing and Pilot Plant Facilities
Multi-purpose cGMP facilities featuring computerized process control, glass line reactors, filter dryers, and liquid isolation capabilities.
Preclinical Manufacturing
Norac Pharma provides preclinical API, starting materials, and intermediates manufacturing services ranging from laboratory scale to large-scale preclinical production.
Services
Process discovery, research and optimization to develop scalable synthetic routes for APIs and intermediates.
Analytical method development, characterization and support for process development and regulatory submissions.
cGMP manufacture of APIs and intermediates at laboratory, kilo and pilot scales for preclinical, clinical and niche commercial supply.
Laboratory-scale production and supply of APIs, starting materials and intermediates intended for preclinical studies.
Quality assurance, quality control and regulatory compliance services including preparation for inspections and maintenance of cGMP systems.
EHS compliance support and continuous performance improvement for process safety and environmental management.
Process discovery, research and optimization to develop scalable synthetic routes for APIs and intermediates.
Analytical method development, characterization and support for process development and regulatory submissions.
cGMP manufacture of APIs and intermediates at laboratory, kilo and pilot scales for preclinical, clinical and niche commercial supply.
Laboratory-scale production and supply of APIs, starting materials and intermediates intended for preclinical studies.
Quality assurance, quality control and regulatory compliance services including preparation for inspections and maintenance of cGMP systems.
EHS compliance support and continuous performance improvement for process safety and environmental management.
Expertise Areas
- API process development
- cGMP API manufacturing and scale-up
- Analytical method development and validation
- Process safety and thermal hazard analysis
Key Technologies
- In-situ FTIR reaction monitoring
- Real-time crystallization monitoring (FBRM)
- Gas chromatography (GC)
- High-performance liquid chromatography (HPLC)
News & Updates
Plan to be in San Diego for the 2008 BIO International Convention, June 17-20, 2008.
Plan to be in San Diego for the 2008 BIO International Convention, June 17-20, 2008.
Norac Pharma will be exhibiting at InformexUSA 2009 at the Moscone South Convention Center, San Francisco, California, January 27 – 30, 2009.
Norac Pharma will be exhibiting at InformexUSA 2011 at the Charlotte Convention Center, Charlotte, North Carolina, February 7– 10, 2011.
Norac Pharma is excited about Informex 2013, back in the Golden State being held from February 19-22, 2013 at the Anaheim Convention Center.
Norac Pharma is happy with the outcomes from Informex USA 2014 held in Miami Beach.
Plan to be in San Diego for the 2008 BIO International Convention, June 17-20, 2008.
Plan to be in San Diego for the 2008 BIO International Convention, June 17-20, 2008.
Norac Pharma will be exhibiting at InformexUSA 2009 at the Moscone South Convention Center, San Francisco, California, January 27 – 30, 2009.
Norac Pharma will be exhibiting at InformexUSA 2011 at the Charlotte Convention Center, Charlotte, North Carolina, February 7– 10, 2011.
Norac Pharma is excited about Informex 2013, back in the Golden State being held from February 19-22, 2013 at the Anaheim Convention Center.
Norac Pharma is happy with the outcomes from Informex USA 2014 held in Miami Beach.