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API SUPPLIERS
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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 2004-010 - Rev 02
Status : Valid
Issue Date : 2020-07-31
Type : Chemical
Substance Number : 1407
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FDF Dossiers
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DOSAGE - CREAM;TOPICAL - 0.77%
USFDA APPLICATION NUMBER - 18748
DOSAGE - SUSPENSION;TOPICAL - 0.77%
USFDA APPLICATION NUMBER - 19824
DOSAGE - GEL;TOPICAL - 0.77% **Federal Regist...DOSAGE - GEL;TOPICAL - 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20519
DOSAGE - SOLUTION;TOPICAL - 8% **Federal Regi...DOSAGE - SOLUTION;TOPICAL - 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21022
DOSAGE - SHAMPOO;TOPICAL - 1%
USFDA APPLICATION NUMBER - 21159
Related Excipient Companies
Seqens
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Ciclopirox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ciclopirox, including repackagers and relabelers. The FDA regulates Ciclopirox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ciclopirox 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 Ciclopirox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ciclopirox supplier is an individual or a company that provides Ciclopirox active pharmaceutical ingredient (API) or Ciclopirox finished formulations upon request. The Ciclopirox suppliers may include Ciclopirox API manufacturers, exporters, distributors and traders.
click here to find a list of Ciclopirox suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ciclopirox DMF (Drug Master File) is a document detailing the whole manufacturing process of Ciclopirox active pharmaceutical ingredient (API) in detail. Different forms of Ciclopirox DMFs exist exist since differing nations have different regulations, such as Ciclopirox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ciclopirox DMF submitted to regulatory agencies in the US is known as a USDMF. Ciclopirox USDMF includes data on Ciclopirox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ciclopirox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ciclopirox suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ciclopirox Drug Master File in Korea (Ciclopirox KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ciclopirox. The MFDS reviews the Ciclopirox KDMF as part of the drug registration process and uses the information provided in the Ciclopirox KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ciclopirox KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ciclopirox API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ciclopirox suppliers with KDMF on PharmaCompass.
A Ciclopirox CEP of the European Pharmacopoeia monograph is often referred to as a Ciclopirox Certificate of Suitability (COS). The purpose of a Ciclopirox CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ciclopirox EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ciclopirox to their clients by showing that a Ciclopirox CEP has been issued for it. The manufacturer submits a Ciclopirox CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ciclopirox CEP holder for the record. Additionally, the data presented in the Ciclopirox CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ciclopirox DMF.
A Ciclopirox CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ciclopirox 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 Ciclopirox suppliers with CEP (COS) 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 Ciclopirox as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ciclopirox 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 Ciclopirox 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 Ciclopirox and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ciclopirox NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ciclopirox suppliers with NDC on PharmaCompass.
Ciclopirox 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 Ciclopirox 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 Ciclopirox GMP manufacturer or Ciclopirox GMP API supplier for your needs.
A Ciclopirox CoA (Certificate of Analysis) is a formal document that attests to Ciclopirox's compliance with Ciclopirox specifications and serves as a tool for batch-level quality control.
Ciclopirox CoA mostly includes findings from lab analyses of a specific batch. For each Ciclopirox 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.
Ciclopirox may be tested according to a variety of international standards, such as European Pharmacopoeia (Ciclopirox EP), Ciclopirox JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ciclopirox USP).
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