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  • CREAM;TOPICAL - 0.005%
  • SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • OINTMENT;TOPICAL - 0.064%;0.005%
  • SUSPENSION;TOPICAL - 0.064%;0.005%
  • AEROSOL, FOAM;TOPICAL - 0.005%

Looking for 112965-21-6 / Calcipotriol API manufacturers, exporters & distributors?

Calcipotriol manufacturers, exporters & distributors 1

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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.

API | Excipient name

Calcipotriol

Synonyms

Calcipotriene, Dovonex, Daivonex, Sorilux, 112965-21-6, Calciptriol

Cas Number

112965-21-6

Unique Ingredient Identifier (UNII)

143NQ3779B

About Calcipotriol

Calcipotriene is a synthetic vitamin D derivative usually formulated for topical dermatological use, antipsoriatic Calcipotriene (calcipotriol) competes equally with active 1,25-hydroxy-2D3 (the natural form of vitamin D) for 1,25-hydroxy-2D3 receptors in regulating cell proliferation and differentiation. It induces differentiation and suppresses proliferation of keratinocytes, reversing abnormal keratinocyte changes in psoriasis, and leads to normalization of epidermal growth. (NCI04)

Calcipotriol Monohydrate Manufacturers

A Calcipotriol Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcipotriol Monohydrate, including repackagers and relabelers. The FDA regulates Calcipotriol Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcipotriol Monohydrate 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 Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Calcipotriol Monohydrate Suppliers

A Calcipotriol Monohydrate supplier is an individual or a company that provides Calcipotriol Monohydrate active pharmaceutical ingredient (API) or Calcipotriol Monohydrate finished formulations upon request. The Calcipotriol Monohydrate suppliers may include Calcipotriol Monohydrate API manufacturers, exporters, distributors and traders.

click here to find a list of Calcipotriol Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Calcipotriol Monohydrate USDMF

A Calcipotriol Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcipotriol Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Calcipotriol Monohydrate DMFs exist exist since differing nations have different regulations, such as Calcipotriol Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Calcipotriol Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcipotriol Monohydrate USDMF includes data on Calcipotriol Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcipotriol Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Calcipotriol Monohydrate suppliers with USDMF on PharmaCompass.

Calcipotriol Monohydrate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Calcipotriol Monohydrate Drug Master File in Japan (Calcipotriol Monohydrate JDMF) empowers Calcipotriol Monohydrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Calcipotriol Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Calcipotriol Monohydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Calcipotriol Monohydrate suppliers with JDMF on PharmaCompass.

Calcipotriol Monohydrate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Calcipotriol Monohydrate Drug Master File in Korea (Calcipotriol Monohydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calcipotriol Monohydrate. The MFDS reviews the Calcipotriol Monohydrate KDMF as part of the drug registration process and uses the information provided in the Calcipotriol Monohydrate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Calcipotriol Monohydrate 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 Monohydrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Calcipotriol Monohydrate suppliers with KDMF on PharmaCompass.

Calcipotriol Monohydrate CEP

A Calcipotriol Monohydrate CEP of the European Pharmacopoeia monograph is often referred to as a Calcipotriol Monohydrate Certificate of Suitability (COS). The purpose of a Calcipotriol Monohydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcipotriol Monohydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcipotriol Monohydrate to their clients by showing that a Calcipotriol Monohydrate CEP has been issued for it. The manufacturer submits a Calcipotriol Monohydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcipotriol Monohydrate CEP holder for the record. Additionally, the data presented in the Calcipotriol Monohydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcipotriol Monohydrate DMF.

A Calcipotriol Monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcipotriol Monohydrate 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 Monohydrate suppliers with CEP (COS) on PharmaCompass.

Calcipotriol Monohydrate WC

A Calcipotriol Monohydrate written confirmation (Calcipotriol Monohydrate WC) is an official document issued by a regulatory agency to a Calcipotriol Monohydrate manufacturer, verifying that the manufacturing facility of a Calcipotriol Monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Calcipotriol Monohydrate APIs or Calcipotriol Monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Calcipotriol Monohydrate WC (written confirmation) as part of the regulatory process.

click here to find a list of Calcipotriol Monohydrate suppliers with Written Confirmation (WC) on PharmaCompass.

Calcipotriol Monohydrate NDC

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 Monohydrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Calcipotriol Monohydrate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Monohydrate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Calcipotriol Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcipotriol Monohydrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Calcipotriol Monohydrate suppliers with NDC on PharmaCompass.

Calcipotriol Monohydrate GMP

Calcipotriol Monohydrate 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 Monohydrate 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 Monohydrate GMP manufacturer or Calcipotriol Monohydrate GMP API supplier for your needs.

Calcipotriol Monohydrate CoA

A Calcipotriol Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Calcipotriol Monohydrate's compliance with Calcipotriol Monohydrate specifications and serves as a tool for batch-level quality control.

Calcipotriol Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Calcipotriol Monohydrate 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 Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcipotriol Monohydrate EP), Calcipotriol Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcipotriol Monohydrate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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