AmbioPharm

CSBio is a leading peptide and peptide synthesizer manufacturing company located on the edge of Silicon Valley in Menlo Park, California. Since 1993, CSBio has been providing high quality custom peptides, cGMP peptides and automated peptide synthesizers to the global biotech community. Our peptide products and peptide synthesis equipment can be found in peptide production laboratories and pharmaceutical companies worldwide.

CSBio now also offers solid phase peptide synthesis resins as well as high quality Fmoc and Boc protected amino acids for use in both R&D and cGMP peptide manufacturing. Our state of the art cGMP manufacturing facility provides cGMP peptides for preclinical and clinical programs and our commercialization and regulatory teams can take you from toxicology studies through market commercialization. Our product line also includes a complete list of generic peptide APIs including the most widely used peptide APIs in the industry. Whatever your peptide requirements, CSBio can assist you in reaching your ultimate goals by offering high quality products and world class support.

LEADING THE SUPPLY OF HIGH QUALITY GENERIC APIs

21st Century economic, social, technical and regulatory dynamics are dramatically changing the pharmaceutical world making it more challenging than ever to find profitable opportunities. That's why it's important to work with a supply-partner who knows how to navigate through the tough issues, help you overcome obstacles and get you to the market fast to gain competitive advantage.

Established in 1982, ChemWerth is a full service generic drug development and supply company providing high quality API's to regulated markets worldwide.

Through exclusive development and partnerships with API manufacturers, ChemWerth provides expertise in product selection and development, analytical and regulatory services, and strong project management to ensure the highest standards of quality.

We are committed to providing our customers with a distinct competitive advantage. Our team of technical, analytical, regulatory and marketing experts can enhance your business by: 1. Advancing your product development; 2. Ensuring the manufacturing facilities we represent maintain a high level of compliance with ever-evolving cGMPs; 3. Collaborating with manufacturers in establishing appropriate protocols and methodologies to prepare a sound and complete DMF; 4. Sourcing APIs from China, India, Germany and the US to provide our customers with the best value; and 5. Advancing Paragraph IV filings through our exclusive API development and supply partnerships.

Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:

Consulting
• CMC Project Management
• GMP Auditing
• Licensing
• Sourcing & Procurement

Drug Discovery
• Medicinal Chemistry

R&D/Pre-Clinical
• Analytical Method Development
• Catalysis Screening
• Crystallization
• Metabolites, Impurities ID & Synthesis
• Process Research
• Reference Standards
• Solid Form Capabilities

Manufacturing (Phase I-III)
• Advanced Intermediate Manufacturing
• API & Commercial Manufacturing
• cGMP Manufacturing
• Final Drug Product Manufacturing
• Formulation Development
• Quality and Regulatory Support
• Raw Material Manufacturing

Chemistry Technology Platforms
Aseptic Fill & Finish
• Chlorination
• Chromatography
• Cryogenic
• Distillation
• Fermentation
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Hydrogenation
• Lyophilization
• Nitration
• Pastillation
• Phosgenation
• Polymorph Screening
• Powder Filling
• X-ray Crystallography

Project Examples
• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product
• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M
• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas
• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product
• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval
• Phase III API for antibody conjugate for oncology identifying key supplier

IRIX Pharmaceuticals, Inc. is a privately held company engaged in the generation of process technology for new and existing drugs.

IRIX offers the full capability of supplying API’s and complex pharma intermediates from pre-clinical stages, through all phases of clinical trials, registration/validation batches, launch and ongoing commercial quantities.

Formed to provide the Pharmaceutical Industry with a low-cost alternative for bringing new drugs to market rapidly, IRIX operates three sites for Process R&D and Clinical through Commercial cGMP production of API’s. Process R&D and early stage clinical supply for API’s is based in Florence, South Carolina. Late-stage clinical supply and commercial production is located in Greenville, South Carolina.

IRIX ensures compliance with all regulatory and quality requirements. Both the Greenville and Florence site were visited by the FDA in 2008 and 2009, respectively, with no 483s issued for either site.

IRIX supports new drug development in all functions necessary to bring a pharmaceutical candidate from discovery to market. IRIX provides seamless technology transfers both to/from Clients and internally for API syntheses.

The demonstrated expertise of the IRIX staff and the company’s emphasis on quality, economics, and timely delivery make it a choice CRMO (Contract Resources and Manufacturing Organization) for innovative pharmaceutical clients desiring to bring new drugs to the market rapidly.

Operating as an extension of the internal resources, IRIX offers sharp process solutions for an accelerated time to market at a very competitive cost.

Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world. We are passionate about making people’s lives better by making high quality medicines more accessible around the world.

The company has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and development hubs in the U.S., Romania, Korea and Taiwan. North America is Alvogen’s single largest market and other key markets include: South Korea, Russia, Taiwan, Romania, Hungary, Ukraine, Japan and China.