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**F...DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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