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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - OINTMENT, AUGMENTED;TOPICAL - EQ 0.0...DOSAGE - OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE
USFDA APPLICATION NUMBER - 18741
DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE;1% **F...DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18827
DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE
USFDA APPLICATION NUMBER - 19137
DOSAGE - OINTMENT;TOPICAL - EQ 0.05% BASE
USFDA APPLICATION NUMBER - 19141
DOSAGE - CREAM, AUGMENTED;TOPICAL - EQ 0.05% ...DOSAGE - CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19555
DOSAGE - LOTION, AUGMENTED;TOPICAL - EQ 0.05%...DOSAGE - LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19716
DOSAGE - OINTMENT;TOPICAL - 0.064%;0.005%
USFDA APPLICATION NUMBER - 21852
DOSAGE - SUSPENSION;TOPICAL - 0.064%;0.005%
USFDA APPLICATION NUMBER - 22185
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
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Digital Content
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Betamethasone Dipropionate 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 Betamethasone Dipropionate manufacturer or Betamethasone Dipropionate supplier for your needs.
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A Diprolene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diprolene, including repackagers and relabelers. The FDA regulates Diprolene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diprolene 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 Diprolene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diprolene supplier is an individual or a company that provides Diprolene active pharmaceutical ingredient (API) or Diprolene finished formulations upon request. The Diprolene suppliers may include Diprolene API manufacturers, exporters, distributors and traders.
click here to find a list of Diprolene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diprolene DMF (Drug Master File) is a document detailing the whole manufacturing process of Diprolene active pharmaceutical ingredient (API) in detail. Different forms of Diprolene DMFs exist exist since differing nations have different regulations, such as Diprolene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diprolene DMF submitted to regulatory agencies in the US is known as a USDMF. Diprolene USDMF includes data on Diprolene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diprolene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diprolene suppliers with USDMF on PharmaCompass.
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 Diprolene Drug Master File in Japan (Diprolene JDMF) empowers Diprolene 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 Diprolene JDMF during the approval evaluation for pharmaceutical products. At the time of Diprolene 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 Diprolene suppliers with JDMF 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 Diprolene Drug Master File in Korea (Diprolene KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Diprolene. The MFDS reviews the Diprolene KDMF as part of the drug registration process and uses the information provided in the Diprolene KDMF to evaluate the safety and efficacy of the drug.
After submitting a Diprolene 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 Diprolene API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Diprolene suppliers with KDMF on PharmaCompass.
A Diprolene CEP of the European Pharmacopoeia monograph is often referred to as a Diprolene Certificate of Suitability (COS). The purpose of a Diprolene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Diprolene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Diprolene to their clients by showing that a Diprolene CEP has been issued for it. The manufacturer submits a Diprolene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Diprolene CEP holder for the record. Additionally, the data presented in the Diprolene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Diprolene DMF.
A Diprolene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Diprolene 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 Diprolene suppliers with CEP (COS) on PharmaCompass.
A Diprolene written confirmation (Diprolene WC) is an official document issued by a regulatory agency to a Diprolene manufacturer, verifying that the manufacturing facility of a Diprolene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Diprolene APIs or Diprolene finished pharmaceutical products to another nation, regulatory agencies frequently require a Diprolene WC (written confirmation) as part of the regulatory process.
click here to find a list of Diprolene 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 Diprolene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Diprolene 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 Diprolene 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 Diprolene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Diprolene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Diprolene suppliers with NDC on PharmaCompass.
Diprolene 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 Diprolene 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 Diprolene GMP manufacturer or Diprolene GMP API supplier for your needs.
A Diprolene CoA (Certificate of Analysis) is a formal document that attests to Diprolene's compliance with Diprolene specifications and serves as a tool for batch-level quality control.
Diprolene CoA mostly includes findings from lab analyses of a specific batch. For each Diprolene 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.
Diprolene may be tested according to a variety of international standards, such as European Pharmacopoeia (Diprolene EP), Diprolene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Diprolene USP).
