HOME | WEBINARS | BLOG | LIBRARY | CONTACT US

 

Contract Manufacturing Directory

A-F G-M N-Q R-Z

AAIPharma Services provides cGMP manufacturing services for clinical and commercial products at its solid dosage and sterile product manufacturing facilities. The facilities located in Charleston, SC (sterile) and Wilmington, NC (solid dose) are comparable in size/staffing and provide flexible capabilities for the processing of a wide range of pharmaceutical drug products, including controlled substances and potent compounds. Clinical manufacturing activity ranges from Phase I through III trials with scale-up and validation support to address commercial launch requirements and to support subsequent commercial supply. Both sites are FDA and MHRA approved and produce products for the US and European markets. www.aaipharma.com

Alpha Biologics provides contract process development and cGMP manufacturing services for mammalian cell products, vaccines or secreted proteins such as monoclonal antibodies. We have process development, optimization and scale-up laboratories in Cambridge, UK and Penang, Malaysia, and also cGMP manufacturing at our facility in Penang. Please visit www.alphabiologics.com for more information.

American Peptide Company is a CMO in the peptide field--we're FDA inspected (4x in 6 years--no 483 comments!) at our cGMP facility near San Diego, and non-GMP production near San Jose. We welcome all inquiries through kilo quantities. www.americanpeptide.com

Apotex Fermentation Inc, Web: www.apoferm.com Address: 50 Scurfield Blvd, Winnipeg, Manitoba R3Y 1G4, Canada. email: services@apoferm.mb.ca, Phone: 204-989-6830

Apotex Fermentation provides contract services in research, process development, scale-up and cGMP manufacturing of microbial fermentation based pharmaceutical products. We strive to develop robust and cost effective processes to help our customers achieve the production of clinical trial to commercial scale materials and CMC filings on time and on budget.

Applied Microarrays is a contract manufacturer of protein and oligo arrays, primarily for diagnostics. We are ISO 13485 registered and provide assay optimization support, functional QC testing, custom packaging and logistics management. Recent projects include lysate arrays, peptide arrays, Ab arrays and oligo arrays for microRNA detection. www.appliedmicroarrays.com

Aptuit has 19 facilities globally supplying the full continuum of drug development and manufacturing services from Discovery through to Commercial API, Drug Product and Packaging. www.aptuit.com

AuroSource is the new CRAMS Business Development and Marketing arm of Aurobindo Pharma Ltd. Aurobindo has been in business since the late 1980's and has grown from an API development company to one of the fastest growing generic pharmaceutical companies headquartered in India. Throughout the expansive facilities and diverse capabilities within Aurobindo, we have carved out capabilities that are providing the value-added, quality partner that most pharmaceutical and biotech companies are searching for in today's environment. We specialize in all aspects of the drug development process from custom API synthesis and production, through CTM and Commercial finished dosage development and manufacturing. Our areas of expertise are too numerous to list, so please visit our website www.aurosource.com

Cangene bioPharma offers contract manufacturing for the aseptic fill/finish of sterile injectables, vials and syringes, liquid and lyophilized. Cangene bioPharma provides both clinical and commercial scale manufacturing with our client’s distributing the products world-wide. Site approvals by: USA-FDA, Europe- EMEA/MHRA and Japan –PDMA. www.cangenbiopharma.com

Chirosolve recently launched contract/custom synthesis business where we focus on metabolites, stable-labeled materials, reference compounds heterocycles-all small molecules. API-chiral or non-chiral . Challenging synthesis with expert network of chemists. We are in Santa Clara, CA and we perform process development and then hand our project to India-China for manufacturing, -under confidential agreements to our partners-GMP- if required. www.chirosolve.com

Cytovance Biologics is a cGMP contract manufacturer of therapeutic proteins and monoclonal antibodies, based in Oklahoma City. Please see our website at www.cytovance.com

Dalton Pharma Services - Canadian company providing numerous services, especially for pharmaceutical companies: contract research (synthesis, analysis), Process Development (scale up of bench processes, optimization), GMP production, sterile filling, formulation. The separate branch of the company provides contract research in Medicinal chemistry. Everything under the same roof. The company sertified by Health Canada (equivalent of FDA, but even more tough). See the company website www.dalton.com

Diablo Sales represents a number of high-end, next generation type manufacturers. We can produce parts, components and assemblies as well as complete devices. Check us out at www.diablosales.com

DPT is the contract development and manufacturing organization (CDMO) that specializes in semi-solid, liquid and sterile dosage forms. With unmatched technical expertise and fully integrated drug development and manufacturing services for sterile and non-sterile dosage forms, we can help you successfully develop and commercialize your next product. Partnering with DPT gives you a seamless transition from pre-formulation to clinical supplies to commercial supply. See more at www.dptlabs.com

DSM BioSolutions offers CMO development and manufacturing services related to cGMP microbial fermentation. DSM has over 100 years experience in fermentation-based technologies. Our production platforms have been developed for a large variety of micro-organisms and a multitude of products, ranging from simple and complex metabolites (e.g. anti-infectives) to highly complex pharmaceutical proteins and enzymes. www.dsm.com

Eden Biodesign is a leading CMO based in the UK with offices in the USA. Eden can provide services from cell line development (IP or IP free), process development to cGMP commercial production for recombinant proteins (Mammalian, Microbial, Viral, Vaccines). Eden is a flexible partner (Cost/Timelines) you can work with being a critical friend for every stage of your development activities. To find out more about Eden please feel free to visit our website: www.edenbiodesign.com

General Medical Manufacturing Corp. is a full service manfacturing company based in Bangor, Pennsylvania. We provide contract sewing services and specialize but are not limited to the medical industry. Please visit us at www.general-medical.net

G&W Laboratories is a contract developer and manufacturer located in South Plainfield, NJ. Our areas of expertise include semi-solids, suppositories, topical solutions and nasal sprays. Our team can take a project from conception through commercialization.www.gwlabs.com

Inno Biologics is a CMO based in Malaysia for cGMP bio-manufacturing and development of monoclonal antibodies and recombinant protein based upon mammalian cell. You may visit our website : www.innobiologics.com

IRIX Pharmaceuticals, based in South Carolina, specializes in process development and manufacturing of small molecule API's for all phases of drug development. IRIX was founded in 1996 and has been inspected by the FDA on several occasions, never receiving any 483's during any inspection. In addition to our traditional pharmaceutical manufacturing capabilities, IRIX offers high potent (HPAPI) manufacturing as well as controlled substance manufacturing with a class I-IV DEA license. For more information please visit our website, www.irixpharma.com

Mark Two Engineering is a contract engineering and manufacturing company specializing in rapid prototyping, rapid manufacturing and complex high-precision machining in the medical device and aerospace industries. Mark Two can fulfill all engineering and manufacturing requests from the prototype stage through high-volume production, assembly and packaging. Please feel free to contact David at davido@marktwo.com with any inquiries. www.marktwo.com

Merck BioManufacturing Network (Formerly Avecia Biologics & Diosynth Biotechnology) is a contract manufacturing organisation based in U.K. and U.S, focussing on microbial and mammalian derived biologics and offers excellent process development.The operation supports the biotechnology and pharmaceutical industries from pre-clinical process invention to post-launch, commercial scale manufacture. For further details, please visit- www.merck.com/bmn

Meridian is a premier provider of contract R&D, process development, and clinical cGMP biomanufacturing for vaccines, viral challenge materials, VLPs, gene therapies, and recombinant proteins in BEVS. We have manufactured a unique RSV Clinical Challenge Virus that can be used to advance development of RSV vaccines or anti-RSV therapeutics (Abs, small molecules, etc.). We have recently completed projects including a dual VLP vaccine (in BEVS), a live Rotavirus Vaccine and live attenuated RSV and Dengue vaccines. MLS is also leading manufacturer of viral antigens, recombinant proteins, monoclonal and polyclonal antibodies, and critical assay reagents for the immunodiagnostics and biopharmaceutical industries. In addition to a catalog of over 5,200 biologic products, we provide custom antigen, antibody and recombinant protein production services. Please visit www.meridianlifescience.com

Patheon’s development and manufacturing capabilities cover prescription (Rx) products in solid, semi-solid and liquid dosage forms, as well as specialized capabilities in high-potency, cephalosporin, controlled/sustained release and sterile manufacturing, including aseptic filling and lyophilization. www.patheon.com

PharmaCell operates a state-of-the-art cGMP-Licenced facility for human cell & tissue culturing and production of (bio) pharmaceuticals located centrally in Europe. We are the CMO of choice to leading biotech companies in this field and are one of very few companies in Europe to hold an official licence as a Registered Tissue Establishment. Pharmacell being a typical CMO can provide additional research, assay validation, QC testing and process optimization support before going to large scale production of human cellular biotherapeutics and IMP’s. Pharmacell also provides assistance (QA dept, qualified person) in drafting regulatory documents for applications on the European market. www.pharmacell.nl/

Pharmatek Laboratories is a contract formulation and clinical manufacturing organization based in San Diego, CA. In business since 1999, our focus is on early-phase drug product development and GMP manufacturing. Pharmatek offers complete drug product service covering dose form needs from preclinical to Phase IIb. And we can safely handle highly potent and cytotoxic compounds.www.pharmatek.com

Pharmaterials Ltd is a UK based pharmaceutical contract service company with comprehensive expertise in preformulation and product development for oral, inhaled and parenteral routes of drug delivery. With MHRA approved cGMP manufacture and analytical services we can also provide a contract manufacturing services for oral and inhaled products.

PharmaVize (Belgium) is a CMO who manufactures and QP releases drug products for Phase I and Phase II clinical studies in Europe and US. PharmaVize has the capability of filling liquid and/or semi solids into had gelatin capsules. Please visit www.pharmavize.be

for more information.

POS Pilot Plant is a confidential contract research, toll processing, and analytical services organization located in Saskatoon, Canada. We specialize in extraction, fractionation, purification and modification of bio-based materials. Health Canada NHP certified site license for manufacturing natural health products, ISO 9000:2008 certified, a cGMP compliant pilot plant working environment, Kosher production capabilities and Canadian Food Inspection Agency (CFIA) site license for manufacturing fish and marine oils (approved to export to the European Union).www.pos.ca

Quay Pharmaceuticals, based in the UK, specialises in the development of small molecule NCEs. Our services include development of most dosage forms, together with analytical development for both the API and the drug product. Quay has particular expertise in the formulation of poorly-soluble APIs, and can manufacture, package and ship clinical supplies for Phase I/Phase II trials. www.quaypharma.com

Regis Technologies develops commercially viable chemical processes and produces small-molecule active pharmaceutical ingredients (APIs) for preclinical, clinical, and small to medium scale commercial use under current Good Manufacturing Practices (GMPs). We help our customers expedite the discovery-to-market timeline by servicing all of their API needs at one facility, such as analytical research, stability, and process validation. Regis can advance your project from the small-scale development stage through final validation and commercial manufacturing. www.registech.com

Randox Pharma Services: Over the past 3 decades, we have been supplying the world’s leading CRO’s, Pharmaceutical and Biotech companies and have built up unrivalled in-house technical know-how, whether in the development of new biomarker assays, companion diagnostics or the manufacture of the highest quality clinical diagnostic reagents and fully customised human and animal quality control sera and calibrators. Visit our website for more information on the services we offer: www.randoxpharmaservices.com

SAFC provides cGMP contract manufacturing services for both small and large molecules via mammalian cell culture, microbial fermentation, plant-based manufacturing, and organic synthesis. Specific expertise in high potent APIs (HPAPIs), Antibody Drug Conjugates (ADCs), and viral vectors/vaccines. Please visit www.safcglobal.com

Shasun Pharmaceticals Limited, is a Chennai , India based Pharma company with CRAMS division. Shasun Research Centre(SRC) , Chennai is a hub centre for Early phase Chemistry development and GMP Kg lab facilities. We have special technologies to provide solutions to highly complex Chiral molecules involving multistep, critical reagents. Chiral - Carbohydrate platform technology provides custom made solutions to your pipeline chemistry development needs. www.shasun.com

SCM Pharma is a UK-based CMO that makes novel, difficult and dangerous drugs on behalf of its clients. The company provides a range of sterile and non-sterile manufacturing services to meet clinical trial and niche/low volume licensed product supply needs. www.scm-pharma.com

Thank You!

Back to Top

Submit Your CMO

Name:
E-mail:
Message:
ANTI SPAM NUMBER:

Enter the number displayed above
I confirm that I will not use this form to send unwanted spam

 

Company BIO
We take advantage of high quality webinar technology. We make an abundance of actionable, premium content easily available. Log in anytime, from anywhere to get exactly what YOU need from our diverse and interactive global network of experts and key opinion leaders.

Featured Content