Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CREAM;TOPICAL - EQ 0.1% BASE
USFDA APPLICATION NUMBER - 18861
DOSAGE - OINTMENT;TOPICAL - EQ 0.1% BASE
USFDA APPLICATION NUMBER - 18865
DOSAGE - LOTION;TOPICAL - EQ 0.1% BASE
USFDA APPLICATION NUMBER - 18866
DOSAGE - AEROSOL, FOAM;TOPICAL - 0.12% **Fede...DOSAGE - AEROSOL, FOAM;TOPICAL - 0.12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20934
Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lubrizol Life Science Health
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Thickeners and Stabilizers
Solubilizers
Emulsifying Agents
Controlled & Modified Release
Parenteral
Film Formers & Plasticizers
Surfactant & Foaming Agents
API Stability Enhancers
Granulation
Lubricants & Glidants
Rheology Modifiers
Taste Masking
Coating Systems & Additives
Direct Compression
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
48
PharmaCompass offers a list of Betamethasone Valerate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Betamethasone Valerate manufacturer or Betamethasone Valerate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betamethasone Valerate manufacturer or Betamethasone Valerate supplier.
A Betnovate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betnovate, including repackagers and relabelers. The FDA regulates Betnovate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betnovate 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 Betnovate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Betnovate supplier is an individual or a company that provides Betnovate active pharmaceutical ingredient (API) or Betnovate finished formulations upon request. The Betnovate suppliers may include Betnovate API manufacturers, exporters, distributors and traders.
click here to find a list of Betnovate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Betnovate DMF (Drug Master File) is a document detailing the whole manufacturing process of Betnovate active pharmaceutical ingredient (API) in detail. Different forms of Betnovate DMFs exist exist since differing nations have different regulations, such as Betnovate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betnovate DMF submitted to regulatory agencies in the US is known as a USDMF. Betnovate USDMF includes data on Betnovate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betnovate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betnovate 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 Betnovate Drug Master File in Japan (Betnovate JDMF) empowers Betnovate 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 Betnovate JDMF during the approval evaluation for pharmaceutical products. At the time of Betnovate 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 Betnovate 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 Betnovate Drug Master File in Korea (Betnovate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Betnovate. The MFDS reviews the Betnovate KDMF as part of the drug registration process and uses the information provided in the Betnovate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Betnovate 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 Betnovate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Betnovate suppliers with KDMF on PharmaCompass.
A Betnovate CEP of the European Pharmacopoeia monograph is often referred to as a Betnovate Certificate of Suitability (COS). The purpose of a Betnovate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betnovate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betnovate to their clients by showing that a Betnovate CEP has been issued for it. The manufacturer submits a Betnovate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betnovate CEP holder for the record. Additionally, the data presented in the Betnovate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betnovate DMF.
A Betnovate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betnovate 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 Betnovate suppliers with CEP (COS) on PharmaCompass.
A Betnovate written confirmation (Betnovate WC) is an official document issued by a regulatory agency to a Betnovate manufacturer, verifying that the manufacturing facility of a Betnovate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Betnovate APIs or Betnovate finished pharmaceutical products to another nation, regulatory agencies frequently require a Betnovate WC (written confirmation) as part of the regulatory process.
click here to find a list of Betnovate 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 Betnovate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Betnovate 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 Betnovate 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 Betnovate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betnovate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Betnovate suppliers with NDC on PharmaCompass.
Betnovate 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 Betnovate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Betnovate GMP manufacturer or Betnovate GMP API supplier for your needs.
A Betnovate CoA (Certificate of Analysis) is a formal document that attests to Betnovate's compliance with Betnovate specifications and serves as a tool for batch-level quality control.
Betnovate CoA mostly includes findings from lab analyses of a specific batch. For each Betnovate 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.
Betnovate may be tested according to a variety of international standards, such as European Pharmacopoeia (Betnovate EP), Betnovate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betnovate USP).
