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API SUPPLIERS
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USDMF
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Minakem
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Sulfasalazine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sulfasalazine manufacturer or Sulfasalazine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulfasalazine manufacturer or Sulfasalazine supplier.
PharmaCompass also assists you with knowing the Sulfasalazine API Price utilized in the formulation of products. Sulfasalazine API Price is not always fixed or binding as the Sulfasalazine Price is obtained through a variety of data sources. The Sulfasalazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sulfasalazine Pfizer Brand manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulfasalazine Pfizer Brand, including repackagers and relabelers. The FDA regulates Sulfasalazine Pfizer Brand manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulfasalazine Pfizer Brand 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 Sulfasalazine Pfizer Brand manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulfasalazine Pfizer Brand supplier is an individual or a company that provides Sulfasalazine Pfizer Brand active pharmaceutical ingredient (API) or Sulfasalazine Pfizer Brand finished formulations upon request. The Sulfasalazine Pfizer Brand suppliers may include Sulfasalazine Pfizer Brand API manufacturers, exporters, distributors and traders.
click here to find a list of Sulfasalazine Pfizer Brand suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulfasalazine Pfizer Brand DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulfasalazine Pfizer Brand active pharmaceutical ingredient (API) in detail. Different forms of Sulfasalazine Pfizer Brand DMFs exist exist since differing nations have different regulations, such as Sulfasalazine Pfizer Brand USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulfasalazine Pfizer Brand DMF submitted to regulatory agencies in the US is known as a USDMF. Sulfasalazine Pfizer Brand USDMF includes data on Sulfasalazine Pfizer Brand's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulfasalazine Pfizer Brand USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulfasalazine Pfizer Brand suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Sulfasalazine Pfizer Brand Drug Master File in Japan (Sulfasalazine Pfizer Brand JDMF) empowers Sulfasalazine Pfizer Brand API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Sulfasalazine Pfizer Brand JDMF during the approval evaluation for pharmaceutical products. At the time of Sulfasalazine Pfizer Brand JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Sulfasalazine Pfizer Brand suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Sulfasalazine Pfizer Brand Drug Master File in Korea (Sulfasalazine Pfizer Brand KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sulfasalazine Pfizer Brand. The MFDS reviews the Sulfasalazine Pfizer Brand KDMF as part of the drug registration process and uses the information provided in the Sulfasalazine Pfizer Brand KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sulfasalazine Pfizer Brand KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sulfasalazine Pfizer Brand API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sulfasalazine Pfizer Brand suppliers with KDMF on PharmaCompass.
A Sulfasalazine Pfizer Brand CEP of the European Pharmacopoeia monograph is often referred to as a Sulfasalazine Pfizer Brand Certificate of Suitability (COS). The purpose of a Sulfasalazine Pfizer Brand CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sulfasalazine Pfizer Brand EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sulfasalazine Pfizer Brand to their clients by showing that a Sulfasalazine Pfizer Brand CEP has been issued for it. The manufacturer submits a Sulfasalazine Pfizer Brand CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sulfasalazine Pfizer Brand CEP holder for the record. Additionally, the data presented in the Sulfasalazine Pfizer Brand CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sulfasalazine Pfizer Brand DMF.
A Sulfasalazine Pfizer Brand CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sulfasalazine Pfizer Brand CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Sulfasalazine Pfizer Brand suppliers with CEP (COS) on PharmaCompass.
A Sulfasalazine Pfizer Brand written confirmation (Sulfasalazine Pfizer Brand WC) is an official document issued by a regulatory agency to a Sulfasalazine Pfizer Brand manufacturer, verifying that the manufacturing facility of a Sulfasalazine Pfizer Brand active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sulfasalazine Pfizer Brand APIs or Sulfasalazine Pfizer Brand finished pharmaceutical products to another nation, regulatory agencies frequently require a Sulfasalazine Pfizer Brand WC (written confirmation) as part of the regulatory process.
click here to find a list of Sulfasalazine Pfizer Brand 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 Sulfasalazine Pfizer Brand as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sulfasalazine Pfizer Brand 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 Sulfasalazine Pfizer Brand 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 Sulfasalazine Pfizer Brand and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sulfasalazine Pfizer Brand NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sulfasalazine Pfizer Brand suppliers with NDC on PharmaCompass.
Sulfasalazine Pfizer Brand 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 Sulfasalazine Pfizer Brand 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 Sulfasalazine Pfizer Brand GMP manufacturer or Sulfasalazine Pfizer Brand GMP API supplier for your needs.
A Sulfasalazine Pfizer Brand CoA (Certificate of Analysis) is a formal document that attests to Sulfasalazine Pfizer Brand's compliance with Sulfasalazine Pfizer Brand specifications and serves as a tool for batch-level quality control.
Sulfasalazine Pfizer Brand CoA mostly includes findings from lab analyses of a specific batch. For each Sulfasalazine Pfizer Brand 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.
Sulfasalazine Pfizer Brand may be tested according to a variety of international standards, such as European Pharmacopoeia (Sulfasalazine Pfizer Brand EP), Sulfasalazine Pfizer Brand JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sulfasalazine Pfizer Brand USP).
