Synopsis
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JDMF
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2015-01-16
DMF Number : 12964
Submission : 1998-04-27
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2015-01-16
DMF Number : 4778
Submission : 1983-01-21
Status :
Type : II
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Certificate Number : CEP 1998-112 - Rev 04
Status : Valid
Issue Date : 2024-02-01
Type : Chemical
Substance Number : 477
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
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...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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API Imports and Exports
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
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PharmaCompass offers a list of Clonidine 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 Clonidine manufacturer or Clonidine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clonidine manufacturer or Clonidine supplier.
PharmaCompass also assists you with knowing the Clonidine API Price utilized in the formulation of products. Clonidine API Price is not always fixed or binding as the Clonidine Price is obtained through a variety of data sources. The Clonidine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Chlophazolin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlophazolin, including repackagers and relabelers. The FDA regulates Chlophazolin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlophazolin 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 Chlophazolin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlophazolin supplier is an individual or a company that provides Chlophazolin active pharmaceutical ingredient (API) or Chlophazolin finished formulations upon request. The Chlophazolin suppliers may include Chlophazolin API manufacturers, exporters, distributors and traders.
click here to find a list of Chlophazolin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlophazolin DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlophazolin active pharmaceutical ingredient (API) in detail. Different forms of Chlophazolin DMFs exist exist since differing nations have different regulations, such as Chlophazolin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlophazolin DMF submitted to regulatory agencies in the US is known as a USDMF. Chlophazolin USDMF includes data on Chlophazolin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlophazolin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlophazolin suppliers with USDMF on PharmaCompass.
A Chlophazolin CEP of the European Pharmacopoeia monograph is often referred to as a Chlophazolin Certificate of Suitability (COS). The purpose of a Chlophazolin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chlophazolin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chlophazolin to their clients by showing that a Chlophazolin CEP has been issued for it. The manufacturer submits a Chlophazolin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chlophazolin CEP holder for the record. Additionally, the data presented in the Chlophazolin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chlophazolin DMF.
A Chlophazolin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chlophazolin 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 Chlophazolin suppliers with CEP (COS) on PharmaCompass.
A Chlophazolin written confirmation (Chlophazolin WC) is an official document issued by a regulatory agency to a Chlophazolin manufacturer, verifying that the manufacturing facility of a Chlophazolin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chlophazolin APIs or Chlophazolin finished pharmaceutical products to another nation, regulatory agencies frequently require a Chlophazolin WC (written confirmation) as part of the regulatory process.
click here to find a list of Chlophazolin 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 Chlophazolin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chlophazolin 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 Chlophazolin 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 Chlophazolin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chlophazolin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chlophazolin suppliers with NDC on PharmaCompass.
Chlophazolin 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 Chlophazolin 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 Chlophazolin GMP manufacturer or Chlophazolin GMP API supplier for your needs.
A Chlophazolin CoA (Certificate of Analysis) is a formal document that attests to Chlophazolin's compliance with Chlophazolin specifications and serves as a tool for batch-level quality control.
Chlophazolin CoA mostly includes findings from lab analyses of a specific batch. For each Chlophazolin 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.
Chlophazolin may be tested according to a variety of international standards, such as European Pharmacopoeia (Chlophazolin EP), Chlophazolin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chlophazolin USP).
