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DOSAGE - CREAM;TOPICAL - 0.005%
USFDA APPLICATION NUMBER - 20554
DOSAGE - SOLUTION;TOPICAL - 0.005% **Federal ...DOSAGE - SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20611
DOSAGE - OINTMENT;TOPICAL - 0.064%;0.005%
USFDA APPLICATION NUMBER - 21852
DOSAGE - SUSPENSION;TOPICAL - 0.064%;0.005%
USFDA APPLICATION NUMBER - 22185
DOSAGE - AEROSOL, FOAM;TOPICAL - 0.005%
USFDA APPLICATION NUMBER - 22563
Related Excipient Companies
EUROAPI
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ABOUT THIS PAGE
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PharmaCompass offers a list of Calcipotriol 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 Calcipotriol manufacturer or Calcipotriol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcipotriol manufacturer or Calcipotriol supplier.
PharmaCompass also assists you with knowing the Calcipotriol API Price utilized in the formulation of products. Calcipotriol API Price is not always fixed or binding as the Calcipotriol Price is obtained through a variety of data sources. The Calcipotriol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Calcipotriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcipotriol, including repackagers and relabelers. The FDA regulates Calcipotriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcipotriol 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 Calcipotriol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcipotriol supplier is an individual or a company that provides Calcipotriol active pharmaceutical ingredient (API) or Calcipotriol finished formulations upon request. The Calcipotriol suppliers may include Calcipotriol API manufacturers, exporters, distributors and traders.
click here to find a list of Calcipotriol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcipotriol DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcipotriol active pharmaceutical ingredient (API) in detail. Different forms of Calcipotriol DMFs exist exist since differing nations have different regulations, such as Calcipotriol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcipotriol DMF submitted to regulatory agencies in the US is known as a USDMF. Calcipotriol USDMF includes data on Calcipotriol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcipotriol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcipotriol 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 Calcipotriol Drug Master File in Korea (Calcipotriol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calcipotriol. The MFDS reviews the Calcipotriol KDMF as part of the drug registration process and uses the information provided in the Calcipotriol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Calcipotriol 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 Calcipotriol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Calcipotriol suppliers with KDMF on PharmaCompass.
A Calcipotriol CEP of the European Pharmacopoeia monograph is often referred to as a Calcipotriol Certificate of Suitability (COS). The purpose of a Calcipotriol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcipotriol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcipotriol to their clients by showing that a Calcipotriol CEP has been issued for it. The manufacturer submits a Calcipotriol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcipotriol CEP holder for the record. Additionally, the data presented in the Calcipotriol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcipotriol DMF.
A Calcipotriol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcipotriol 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 Calcipotriol 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 Calcipotriol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Calcipotriol 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 Calcipotriol 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 Calcipotriol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcipotriol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Calcipotriol suppliers with NDC on PharmaCompass.
Calcipotriol 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 Calcipotriol 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 Calcipotriol GMP manufacturer or Calcipotriol GMP API supplier for your needs.
A Calcipotriol CoA (Certificate of Analysis) is a formal document that attests to Calcipotriol's compliance with Calcipotriol specifications and serves as a tool for batch-level quality control.
Calcipotriol CoA mostly includes findings from lab analyses of a specific batch. For each Calcipotriol 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.
Calcipotriol may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcipotriol EP), Calcipotriol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcipotriol USP).
