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KDMF
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Canada
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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API SUPPLIERS
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Suanfarma, at the Core of a Better Life.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
NDC 
ASMF
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
CEP/COS
NDC
ASMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
NDC
ASMF
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USDMF
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Certificate Number : R1-CEP 2003-251 - Rev 06
Status : Valid
Issue Date : 2022-02-09
Type : Chemical
Substance Number : 997
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...
Suanfarma, at the Core of a Better Life.
About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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Drugs in Development
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REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Enclomiphene Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enclomiphene Citrate, including repackagers and relabelers. The FDA regulates Enclomiphene Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enclomiphene Citrate 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 Enclomiphene Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Enclomiphene Citrate supplier is an individual or a company that provides Enclomiphene Citrate active pharmaceutical ingredient (API) or Enclomiphene Citrate finished formulations upon request. The Enclomiphene Citrate suppliers may include Enclomiphene Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Enclomiphene Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Enclomiphene Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Enclomiphene Citrate active pharmaceutical ingredient (API) in detail. Different forms of Enclomiphene Citrate DMFs exist exist since differing nations have different regulations, such as Enclomiphene Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enclomiphene Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Enclomiphene Citrate USDMF includes data on Enclomiphene Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enclomiphene Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Enclomiphene Citrate 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 Enclomiphene Citrate Drug Master File in Japan (Enclomiphene Citrate JDMF) empowers Enclomiphene Citrate 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 Enclomiphene Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Enclomiphene Citrate 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 Enclomiphene Citrate suppliers with JDMF on PharmaCompass.
A Enclomiphene Citrate CEP of the European Pharmacopoeia monograph is often referred to as a Enclomiphene Citrate Certificate of Suitability (COS). The purpose of a Enclomiphene Citrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Enclomiphene Citrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Enclomiphene Citrate to their clients by showing that a Enclomiphene Citrate CEP has been issued for it. The manufacturer submits a Enclomiphene Citrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Enclomiphene Citrate CEP holder for the record. Additionally, the data presented in the Enclomiphene Citrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Enclomiphene Citrate DMF.
A Enclomiphene Citrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Enclomiphene Citrate 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 Enclomiphene Citrate suppliers with CEP (COS) on PharmaCompass.
A Enclomiphene Citrate written confirmation (Enclomiphene Citrate WC) is an official document issued by a regulatory agency to a Enclomiphene Citrate manufacturer, verifying that the manufacturing facility of a Enclomiphene Citrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Enclomiphene Citrate APIs or Enclomiphene Citrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Enclomiphene Citrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Enclomiphene Citrate 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 Enclomiphene Citrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Enclomiphene Citrate 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 Enclomiphene Citrate 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 Enclomiphene Citrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Enclomiphene Citrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Enclomiphene Citrate suppliers with NDC on PharmaCompass.
Enclomiphene Citrate 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 Enclomiphene Citrate 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 Enclomiphene Citrate GMP manufacturer or Enclomiphene Citrate GMP API supplier for your needs.
A Enclomiphene Citrate CoA (Certificate of Analysis) is a formal document that attests to Enclomiphene Citrate's compliance with Enclomiphene Citrate specifications and serves as a tool for batch-level quality control.
Enclomiphene Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Enclomiphene Citrate 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.
Enclomiphene Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Enclomiphene Citrate EP), Enclomiphene Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Enclomiphene Citrate USP).
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