API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
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Other Certificates
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Other Suppliers
USA (Orange Book)
Europe
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Canada
Australia
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South Africa
Uploaded Dossiers
U.S. Medicaid
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PharmaCompass offers a list of Phenylbutazone 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 Phenylbutazone manufacturer or Phenylbutazone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenylbutazone manufacturer or Phenylbutazone supplier.
PharmaCompass also assists you with knowing the Phenylbutazone API Price utilized in the formulation of products. Phenylbutazone API Price is not always fixed or binding as the Phenylbutazone Price is obtained through a variety of data sources. The Phenylbutazone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MolPort-001-783-564 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-001-783-564, including repackagers and relabelers. The FDA regulates MolPort-001-783-564 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-001-783-564 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 MolPort-001-783-564 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MolPort-001-783-564 supplier is an individual or a company that provides MolPort-001-783-564 active pharmaceutical ingredient (API) or MolPort-001-783-564 finished formulations upon request. The MolPort-001-783-564 suppliers may include MolPort-001-783-564 API manufacturers, exporters, distributors and traders.
click here to find a list of MolPort-001-783-564 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MolPort-001-783-564 DMF (Drug Master File) is a document detailing the whole manufacturing process of MolPort-001-783-564 active pharmaceutical ingredient (API) in detail. Different forms of MolPort-001-783-564 DMFs exist exist since differing nations have different regulations, such as MolPort-001-783-564 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MolPort-001-783-564 DMF submitted to regulatory agencies in the US is known as a USDMF. MolPort-001-783-564 USDMF includes data on MolPort-001-783-564's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MolPort-001-783-564 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A MolPort-001-783-564 CEP of the European Pharmacopoeia monograph is often referred to as a MolPort-001-783-564 Certificate of Suitability (COS). The purpose of a MolPort-001-783-564 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MolPort-001-783-564 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MolPort-001-783-564 to their clients by showing that a MolPort-001-783-564 CEP has been issued for it. The manufacturer submits a MolPort-001-783-564 CEP (COS) as part of the market authorization procedure, and it takes on the role of a MolPort-001-783-564 CEP holder for the record. Additionally, the data presented in the MolPort-001-783-564 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MolPort-001-783-564 DMF.
A MolPort-001-783-564 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MolPort-001-783-564 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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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 MolPort-001-783-564 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MolPort-001-783-564 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 MolPort-001-783-564 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 MolPort-001-783-564 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MolPort-001-783-564 NDC to their finished compounded human drug products, they may choose to do so.
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MolPort-001-783-564 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 MolPort-001-783-564 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 MolPort-001-783-564 GMP manufacturer or MolPort-001-783-564 GMP API supplier for your needs.
A MolPort-001-783-564 CoA (Certificate of Analysis) is a formal document that attests to MolPort-001-783-564's compliance with MolPort-001-783-564 specifications and serves as a tool for batch-level quality control.
MolPort-001-783-564 CoA mostly includes findings from lab analyses of a specific batch. For each MolPort-001-783-564 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.
MolPort-001-783-564 may be tested according to a variety of international standards, such as European Pharmacopoeia (MolPort-001-783-564 EP), MolPort-001-783-564 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MolPort-001-783-564 USP).