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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 Penlac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penlac, including repackagers and relabelers. The FDA regulates Penlac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penlac 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 Penlac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Penlac supplier is an individual or a company that provides Penlac active pharmaceutical ingredient (API) or Penlac finished formulations upon request. The Penlac suppliers may include Penlac API manufacturers, exporters, distributors and traders.
click here to find a list of Penlac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Penlac DMF (Drug Master File) is a document detailing the whole manufacturing process of Penlac active pharmaceutical ingredient (API) in detail. Different forms of Penlac DMFs exist exist since differing nations have different regulations, such as Penlac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Penlac DMF submitted to regulatory agencies in the US is known as a USDMF. Penlac USDMF includes data on Penlac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Penlac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Penlac 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 Penlac Drug Master File in Korea (Penlac KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Penlac. The MFDS reviews the Penlac KDMF as part of the drug registration process and uses the information provided in the Penlac KDMF to evaluate the safety and efficacy of the drug.
After submitting a Penlac 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 Penlac API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Penlac suppliers with KDMF on PharmaCompass.
A Penlac CEP of the European Pharmacopoeia monograph is often referred to as a Penlac Certificate of Suitability (COS). The purpose of a Penlac CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Penlac EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Penlac to their clients by showing that a Penlac CEP has been issued for it. The manufacturer submits a Penlac CEP (COS) as part of the market authorization procedure, and it takes on the role of a Penlac CEP holder for the record. Additionally, the data presented in the Penlac CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Penlac DMF.
A Penlac CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Penlac 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 Penlac suppliers with CEP (COS) on PharmaCompass.
A Penlac written confirmation (Penlac WC) is an official document issued by a regulatory agency to a Penlac manufacturer, verifying that the manufacturing facility of a Penlac active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Penlac APIs or Penlac finished pharmaceutical products to another nation, regulatory agencies frequently require a Penlac WC (written confirmation) as part of the regulatory process.
click here to find a list of Penlac 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 Penlac as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Penlac 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 Penlac 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 Penlac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Penlac NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Penlac suppliers with NDC on PharmaCompass.
Penlac 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 Penlac 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 Penlac GMP manufacturer or Penlac GMP API supplier for your needs.
A Penlac CoA (Certificate of Analysis) is a formal document that attests to Penlac's compliance with Penlac specifications and serves as a tool for batch-level quality control.
Penlac CoA mostly includes findings from lab analyses of a specific batch. For each Penlac 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.
Penlac may be tested according to a variety of international standards, such as European Pharmacopoeia (Penlac EP), Penlac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Penlac USP).
