Synopsis
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JDMF
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
NDC 
ASMF, CA
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
CEP/COS
NDC
ASMF, CA
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USDMF
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Drugs in Development
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DOSAGE - TABLET;ORAL - 0.1MG **Federal Regist...DOSAGE - TABLET;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17407
DOSAGE - TABLET;ORAL - 0.2MG **Federal Regist...DOSAGE - TABLET;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17407
DOSAGE - TABLET;ORAL - 0.3MG **Federal Regist...DOSAGE - TABLET;ORAL - 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17407
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 0.1M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22331
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 0.2M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22331
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Clonidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clonidine, including repackagers and relabelers. The FDA regulates Clonidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clonidine 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 Clonidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clonidine supplier is an individual or a company that provides Clonidine active pharmaceutical ingredient (API) or Clonidine finished formulations upon request. The Clonidine suppliers may include Clonidine API manufacturers, exporters, distributors and traders.
click here to find a list of Clonidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clonidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Clonidine active pharmaceutical ingredient (API) in detail. Different forms of Clonidine DMFs exist exist since differing nations have different regulations, such as Clonidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clonidine DMF submitted to regulatory agencies in the US is known as a USDMF. Clonidine USDMF includes data on Clonidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clonidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clonidine suppliers with USDMF on PharmaCompass.
A Clonidine CEP of the European Pharmacopoeia monograph is often referred to as a Clonidine Certificate of Suitability (COS). The purpose of a Clonidine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clonidine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clonidine to their clients by showing that a Clonidine CEP has been issued for it. The manufacturer submits a Clonidine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clonidine CEP holder for the record. Additionally, the data presented in the Clonidine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clonidine DMF.
A Clonidine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clonidine 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 Clonidine suppliers with CEP (COS) on PharmaCompass.
A Clonidine written confirmation (Clonidine WC) is an official document issued by a regulatory agency to a Clonidine manufacturer, verifying that the manufacturing facility of a Clonidine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Clonidine APIs or Clonidine finished pharmaceutical products to another nation, regulatory agencies frequently require a Clonidine WC (written confirmation) as part of the regulatory process.
click here to find a list of Clonidine 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 Clonidine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clonidine 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 Clonidine 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 Clonidine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clonidine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Clonidine suppliers with NDC on PharmaCompass.
Clonidine 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 Clonidine 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 Clonidine GMP manufacturer or Clonidine GMP API supplier for your needs.
A Clonidine CoA (Certificate of Analysis) is a formal document that attests to Clonidine's compliance with Clonidine specifications and serves as a tool for batch-level quality control.
Clonidine CoA mostly includes findings from lab analyses of a specific batch. For each Clonidine 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.
Clonidine may be tested according to a variety of international standards, such as European Pharmacopoeia (Clonidine EP), Clonidine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clonidine USP).
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