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发布时间: 2019 - 11 - 14
SIO HistorySIO’s beginnings date back to 1907, and today, is one of the most important global pharmaceutical oil manufacturer.As a subsidiary of Archer Daniels Midland Company since 1996, our company manufactures state-of-the-art purified pharmaceutical oils that can be used as APIs or as excipients for oral, topical and injectable formulations of oil-soluble drugs. With more than a century of experience in the manufacture of specialty oils, we also offer the best ingredients of vegetable origin for various applications in human and animal nutrition (e.g. hydrogenated vegetable oils for encapsulation) and cosmetic industries (e.g. high melting point vegetable oils and butters).On the below historical timeline, you have an overview on the major steps that made ADM-SIO become a key player in...
发布时间: 2017 - 07 - 05
CP Kelco, a Huber company, is an innovation leader in the production of polysaccharides by microbial fermentation, extraction from land and sea plants and modification of cellulose based raw materials. With over 200 years of experience, they are experts in hydrocolloid manufacturing, modification and application.Through the use of nature based chemistry, CP Kelco strives to provide products such as Xanthan Gum, Gellan Gum and Carboxymethylcellulose Sodium with minimal modifications. These hydrocolloids in turn serve multiple functions such as viscosity modification, thickening agent, suspension stabilization and gelation.With operations in several diverse global markets and a focus on responsible business practices, environmental stewardship and ethical conduct, the company has reached gre...
发布时间: 2021 - 01 - 06
Created in 1863, Solvay is a global company driven by proud and committed chemists. Headquartered in Brussels, Belgium, they have a specialized range of products that serve diversified markets worldwide, from consumer goods to energy to Pharma customers. Their focus is on improving quality of life along with excellent customer performance. Recently, Cytec Industries Inc. was acquired by Solvay and this acquisition has created a global leader in the specialty products and chemical industry resulting  in a stronger and dynamic organization that continues to focus on customer support with their high quality products. They are pioneers in the manufacture of Docusate Sodium (DSS), a versatile and highly effective anionic surfactant used across a variety of pharmaceutical applications....
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BioSpectra
产品名称:

BioSpectra

上市日期: 2020-02-26

Country of Origin: USA

Tris - Trometamol

UREA 

Potassium Bromide

BioSpectra


Company Profile


BioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multistep purification for both traditional and bio-pharmaceutical applications.  Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DMF submissions.  All our manufacturing processes are fully validated.  Our US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources. Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled.  We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, operating under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.



PREMIUM PHARMACEUTICAL INGREDIENTS - MANUFACTURED EXCLUSIVELY IN THE USA


GMP Product Categories

• Active Substances

• GMP Custom Products

• Excipients and Key Ingredients

• GMP Process Chemicals and Solutions

• Bulk, GMP Biological Buffers & Denaturants


Custom GMP Products

• Purification of Key Ingredients

• Full GMP Product Development

• Small Molecule Custom Synthesis

• API Development & Manufacturing

• GMP Compounded Solvents & Solutions


Comprehensive Quality and Regulatory Program

• FDA Registered and Inspected

• Document Support - DMF Submissions

• FDA & ICH Q7 Guidance for Drug Substances

• Global GMP Requirements – US, IPEC, ICH Q7

• State-of-the-art Instrumentation & Laboratories


Corporate Values & Commitments

• True GMP Product Claim – Always Synthesized and/or Purified not simply tested and repackaged

• Reliable, Consistent, Uniform, Quality-Based Manufacturing of Premium Pharmaceutical Ingredients

• Authentic, Secure Supply Chain - 100% Traceable Raw Materials from Qualified Sources

• Fully Validated GMP Manufacturing Systems & Qualified Equipment

• Exclusively Manufactured in the USA


Comprehensive Quality & Regulatory System

• FDA Registered & Inspected

• Full Transparency in Documentation

• Stringent Quality Program & Controls

• Document Support – DMF Submissions

• Rigorous compliance to Global Standards

• FDA & ICH Q7 Guidance for Drug Substances

• Global GMP Requirements – US, IPEC, ICH Q7

• State-of-the-art Instrumentation & Laboratories

• Culture of Embracing Evolving Regulatory Demands

• Complete Testing of all Raw Material and Finished Products


BioSpectra offers four different grades of its materials from two manufacturing sites in Pennsylvania. Each grade of material is manufactured to meet specific end-use needs.


Bio Active Grade products are manufactured in our Bangor, PA facility, which is registered and inspected by the Federal Food and Drug Administration, in accordance with ICH Q7 guidelines incorporating qualified equipment and utilities, validated processes and fully traceable supply chains. Type II Drug Master Files may be referenced through a supply agreement.


Bio Excipient Grade products manufactured in accordance with ICH Q7 guidelines and Bio Pharma Grade products manufactured in accordance with IPEC guidelines are produced in our Bangor, PA and Stroudsburg, PA facilities.


Bio Active LBLE Grade products are intended for use in sterile applications. These products are manufactured in our Bangor, PA facility, which is registered and inspected by the Federal Food and Drug Administration, in accordance with ICH Q7 guidelines incorporating qualified equipment and utilities, validated processes and fully traceable supply chains. Type II Drug Master Files may be referenced through a supply agreement.


For more information, please visit: https://www.biospectra.us/technical/manufacturing-capabilities

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