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API SUPPLIERS
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USDMF
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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Certificate Number : R1-CEP 2010-022 - Rev 00
Status : Valid
Issue Date : 2016-03-23
Type : Chemical
Substance Number : 1302
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Certificate Number : R1-CEP 2001-370 - Rev 05
Status : Valid
Issue Date : 2020-07-30
Type : Chemical
Substance Number : 1302
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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...
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 ...
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
About the Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our c...
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Nanjing Well Pharmaceutical
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PharmaCompass offers a list of Ciclopirox Olamine 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 Ciclopirox Olamine manufacturer or Ciclopirox Olamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ciclopirox Olamine manufacturer or Ciclopirox Olamine supplier.
PharmaCompass also assists you with knowing the Ciclopirox Olamine API Price utilized in the formulation of products. Ciclopirox Olamine API Price is not always fixed or binding as the Ciclopirox Olamine Price is obtained through a variety of data sources. The Ciclopirox Olamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Batrafen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Batrafen, including repackagers and relabelers. The FDA regulates Batrafen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Batrafen 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 Batrafen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Batrafen supplier is an individual or a company that provides Batrafen active pharmaceutical ingredient (API) or Batrafen finished formulations upon request. The Batrafen suppliers may include Batrafen API manufacturers, exporters, distributors and traders.
click here to find a list of Batrafen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Batrafen DMF (Drug Master File) is a document detailing the whole manufacturing process of Batrafen active pharmaceutical ingredient (API) in detail. Different forms of Batrafen DMFs exist exist since differing nations have different regulations, such as Batrafen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Batrafen DMF submitted to regulatory agencies in the US is known as a USDMF. Batrafen USDMF includes data on Batrafen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Batrafen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Batrafen 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 Batrafen Drug Master File in Korea (Batrafen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Batrafen. The MFDS reviews the Batrafen KDMF as part of the drug registration process and uses the information provided in the Batrafen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Batrafen 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 Batrafen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Batrafen suppliers with KDMF on PharmaCompass.
A Batrafen CEP of the European Pharmacopoeia monograph is often referred to as a Batrafen Certificate of Suitability (COS). The purpose of a Batrafen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Batrafen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Batrafen to their clients by showing that a Batrafen CEP has been issued for it. The manufacturer submits a Batrafen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Batrafen CEP holder for the record. Additionally, the data presented in the Batrafen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Batrafen DMF.
A Batrafen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Batrafen 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 Batrafen suppliers with CEP (COS) on PharmaCompass.
A Batrafen written confirmation (Batrafen WC) is an official document issued by a regulatory agency to a Batrafen manufacturer, verifying that the manufacturing facility of a Batrafen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Batrafen APIs or Batrafen finished pharmaceutical products to another nation, regulatory agencies frequently require a Batrafen WC (written confirmation) as part of the regulatory process.
click here to find a list of Batrafen 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 Batrafen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Batrafen 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 Batrafen 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 Batrafen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Batrafen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Batrafen suppliers with NDC on PharmaCompass.
Batrafen 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 Batrafen 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 Batrafen GMP manufacturer or Batrafen GMP API supplier for your needs.
A Batrafen CoA (Certificate of Analysis) is a formal document that attests to Batrafen's compliance with Batrafen specifications and serves as a tool for batch-level quality control.
Batrafen CoA mostly includes findings from lab analyses of a specific batch. For each Batrafen 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.
Batrafen may be tested according to a variety of international standards, such as European Pharmacopoeia (Batrafen EP), Batrafen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Batrafen USP).
