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