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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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Co-Processed Excipients
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Direct Compression
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Digital Content
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Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A OLSALAZINE SODIUM manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of OLSALAZINE SODIUM, including repackagers and relabelers. The FDA regulates OLSALAZINE SODIUM manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. OLSALAZINE SODIUM API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of OLSALAZINE SODIUM manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A OLSALAZINE SODIUM supplier is an individual or a company that provides OLSALAZINE SODIUM active pharmaceutical ingredient (API) or OLSALAZINE SODIUM finished formulations upon request. The OLSALAZINE SODIUM suppliers may include OLSALAZINE SODIUM API manufacturers, exporters, distributors and traders.
click here to find a list of OLSALAZINE SODIUM suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A OLSALAZINE SODIUM DMF (Drug Master File) is a document detailing the whole manufacturing process of OLSALAZINE SODIUM active pharmaceutical ingredient (API) in detail. Different forms of OLSALAZINE SODIUM DMFs exist exist since differing nations have different regulations, such as OLSALAZINE SODIUM USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A OLSALAZINE SODIUM DMF submitted to regulatory agencies in the US is known as a USDMF. OLSALAZINE SODIUM USDMF includes data on OLSALAZINE SODIUM's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The OLSALAZINE SODIUM USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of OLSALAZINE SODIUM suppliers with USDMF on PharmaCompass.
A OLSALAZINE SODIUM written confirmation (OLSALAZINE SODIUM WC) is an official document issued by a regulatory agency to a OLSALAZINE SODIUM manufacturer, verifying that the manufacturing facility of a OLSALAZINE SODIUM active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting OLSALAZINE SODIUM APIs or OLSALAZINE SODIUM finished pharmaceutical products to another nation, regulatory agencies frequently require a OLSALAZINE SODIUM WC (written confirmation) as part of the regulatory process.
click here to find a list of OLSALAZINE SODIUM suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing OLSALAZINE SODIUM as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for OLSALAZINE SODIUM API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture OLSALAZINE SODIUM as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain OLSALAZINE SODIUM and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a OLSALAZINE SODIUM NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of OLSALAZINE SODIUM suppliers with NDC on PharmaCompass.
OLSALAZINE SODIUM Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of OLSALAZINE SODIUM GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right OLSALAZINE SODIUM GMP manufacturer or OLSALAZINE SODIUM GMP API supplier for your needs.
A OLSALAZINE SODIUM CoA (Certificate of Analysis) is a formal document that attests to OLSALAZINE SODIUM's compliance with OLSALAZINE SODIUM specifications and serves as a tool for batch-level quality control.
OLSALAZINE SODIUM CoA mostly includes findings from lab analyses of a specific batch. For each OLSALAZINE SODIUM CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
OLSALAZINE SODIUM may be tested according to a variety of international standards, such as European Pharmacopoeia (OLSALAZINE SODIUM EP), OLSALAZINE SODIUM JP (Japanese Pharmacopeia) and the US Pharmacopoeia (OLSALAZINE SODIUM USP).
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