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API SUPPLIERS
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-13
Pay. Date : 2016-09-28
DMF Number : 30833
Submission : 2016-09-28
Status :
Type : II
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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, 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.
A Depamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Depamine, including repackagers and relabelers. The FDA regulates Depamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Depamine 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 Depamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Depamine supplier is an individual or a company that provides Depamine active pharmaceutical ingredient (API) or Depamine finished formulations upon request. The Depamine suppliers may include Depamine API manufacturers, exporters, distributors and traders.
click here to find a list of Depamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Depamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Depamine active pharmaceutical ingredient (API) in detail. Different forms of Depamine DMFs exist exist since differing nations have different regulations, such as Depamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Depamine DMF submitted to regulatory agencies in the US is known as a USDMF. Depamine USDMF includes data on Depamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Depamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Depamine suppliers with USDMF on PharmaCompass.
A Depamine CEP of the European Pharmacopoeia monograph is often referred to as a Depamine Certificate of Suitability (COS). The purpose of a Depamine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Depamine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Depamine to their clients by showing that a Depamine CEP has been issued for it. The manufacturer submits a Depamine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Depamine CEP holder for the record. Additionally, the data presented in the Depamine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Depamine DMF.
A Depamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Depamine 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 Depamine suppliers with CEP (COS) on PharmaCompass.
A Depamine written confirmation (Depamine WC) is an official document issued by a regulatory agency to a Depamine manufacturer, verifying that the manufacturing facility of a Depamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Depamine APIs or Depamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Depamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Depamine 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 Depamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Depamine 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 Depamine 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 Depamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Depamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Depamine suppliers with NDC on PharmaCompass.
Depamine 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 Depamine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Depamine GMP manufacturer or Depamine GMP API supplier for your needs.
A Depamine CoA (Certificate of Analysis) is a formal document that attests to Depamine's compliance with Depamine specifications and serves as a tool for batch-level quality control.
Depamine CoA mostly includes findings from lab analyses of a specific batch. For each Depamine 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.
Depamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Depamine EP), Depamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Depamine USP).
