BioSpectra (BSI) a leader in manufacturing cGMP pharmaceutical-grade ingredients, including biological buffers, actives, excipients, cGMP process chemicals, as well as new chemical entities (NCEs) at IPEC & ICH Q7 regulatory compliance levels. They specializes in small molecule synthesis and true, phase-change multi-step purification, providing solutions for various key ingredient issues at various stages of the drug manufacturing process.

BioSpectra supports key biopharmaceutical companies for a unique range of critical cGMP products used upstream and downstream, including ingredients for the final drug product. BioSpectra is committed to being a leading manufacturer of pharmaceutical ingredients by having a successful track record in their adaptability, customer-centric operational models, and exceptional customer care and support. This model of customer-oriented products and services has allowed BioSpectra to service and supply products to many of the industry’s leading global Pharma and Biopharmaceutical companies.

As a global leader in the distribution of specialty chemicals and ingredients, Univar Solutions brings best-in-class solutions, industry-leading services, and market knowledge to support BioSpectra’s product portfolio.

BioSpectra represents consistent high quality, uniformly manufactured pharmaceutical ingredients that are always synthesized, purified, or compounded under true cGMP standards.

GMP Product Categories

• Active substances
• GMP custom products
• Excipients and key ingredients
• GMP process chemicals and solutions
• Bulk, GMP biological buffers, and denaturants

Custom GMP Products

• Purification of key ingredients
• Full GMP product development
• Small molecule custom synthesis
• API development and manufacturing
• GMP compounded solvents and solutions

Low Bioburden, Low Endotoxin (LBLE)                              
Low Elemental Impurities (LEI)                              
Water for Injection (WFI)

BioSpectra seeks to service customers who:

ARE SEEKING:

• Increased security of supply
• A strong growth model to support future commercial demands
• A proven track record of commitment to the pharmaceutical industry
• A focus on customer needs
• A flexible, transparent and responsive supplier
• Commitments to sustainable solutions
• Investments in future technology

ARE REALIZING:

• The need for critical ingredient issues that falls within BioSpectra's scope of chemistry and capabilities
• The need for higher-purity, higher-compliance pharmaceutical ingredients
• The value of U.S. manufactured, true-GMP APIs, excipients and key ingredients

BioSpectra is committed to the ideals of sustainability and has launched a three-year thirty million dollar capital investment program to help achieve these goals. BioSpectra is currently working on an external program and has registered with ECOVADIS.

BioSpectra is fundamentally committed to the ideals of supply chain security. They prosecute an aggressive raw material supplier qualification program and take very seriously the global supply-chain situation assessing and reacting to threats with real solutions. BioSpectra is in its second year of actively expanding their raw material supply base to other regions of the world for any raw material or intermediate that is currently sole sourced in China.

With locations worldwide, a best-in-class distribution network, and partnerships with leading suppliers such as BioSpectra, Univar Solutions is proud to help customers quickly source the quality pharmaceutical ingredients they need, wherever they need them.

Univar Solutions Inc. and its affiliates (“Univar”) provide information on products referenced herein as the information and data is conveyed to Univar by the referenced manufacturer. Univar has not subjected the product to any testing for performance, efficacy or safety. Please refer to regulations in your region and consult with regulatory experts prior to making any claim or formulating and distributing any products.

Univar has not investigated the product claims made herein by the manufacturer of any product. Univar makes no warranties, express or implied, related to the products INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. All product claims are based solely upon the claims of the respective manufacturers.

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BEFORE USE, YOU MUST TEST THE PRODUCT, OR ANY VARIANCE THEREOF, TO DETERMINE ITS PERFORMANCE, EFFICACY AND SAFETY. FURTHERMORE, IT IS YOUR RESPONSIBILITY TO OBTAIN ANY NECESSARY GOVERNMENT CLEARANCE, LICENSE OR REGISTRATION.