Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
API Stability Enhancers
Solubilizers
Thickeners and Stabilizers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
89
PharmaCompass offers a list of Betamethasone Sodium Phosphate 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 Sodium Phosphate manufacturer or Betamethasone Sodium Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betamethasone Sodium Phosphate manufacturer or Betamethasone Sodium Phosphate supplier.
A Bentelan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bentelan, including repackagers and relabelers. The FDA regulates Bentelan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bentelan 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 Bentelan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Bentelan supplier is an individual or a company that provides Bentelan active pharmaceutical ingredient (API) or Bentelan finished formulations upon request. The Bentelan suppliers may include Bentelan API manufacturers, exporters, distributors and traders.
click here to find a list of Bentelan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Bentelan DMF (Drug Master File) is a document detailing the whole manufacturing process of Bentelan active pharmaceutical ingredient (API) in detail. Different forms of Bentelan DMFs exist exist since differing nations have different regulations, such as Bentelan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bentelan DMF submitted to regulatory agencies in the US is known as a USDMF. Bentelan USDMF includes data on Bentelan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bentelan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bentelan 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 Bentelan Drug Master File in Japan (Bentelan JDMF) empowers Bentelan 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 Bentelan JDMF during the approval evaluation for pharmaceutical products. At the time of Bentelan 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 Bentelan 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 Bentelan Drug Master File in Korea (Bentelan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bentelan. The MFDS reviews the Bentelan KDMF as part of the drug registration process and uses the information provided in the Bentelan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bentelan 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 Bentelan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bentelan suppliers with KDMF on PharmaCompass.
A Bentelan CEP of the European Pharmacopoeia monograph is often referred to as a Bentelan Certificate of Suitability (COS). The purpose of a Bentelan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bentelan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bentelan to their clients by showing that a Bentelan CEP has been issued for it. The manufacturer submits a Bentelan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bentelan CEP holder for the record. Additionally, the data presented in the Bentelan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bentelan DMF.
A Bentelan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bentelan 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 Bentelan suppliers with CEP (COS) on PharmaCompass.
A Bentelan written confirmation (Bentelan WC) is an official document issued by a regulatory agency to a Bentelan manufacturer, verifying that the manufacturing facility of a Bentelan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bentelan APIs or Bentelan finished pharmaceutical products to another nation, regulatory agencies frequently require a Bentelan WC (written confirmation) as part of the regulatory process.
click here to find a list of Bentelan 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 Bentelan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bentelan 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 Bentelan 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 Bentelan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bentelan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bentelan suppliers with NDC on PharmaCompass.
Bentelan 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 Bentelan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bentelan GMP manufacturer or Bentelan GMP API supplier for your needs.
A Bentelan CoA (Certificate of Analysis) is a formal document that attests to Bentelan's compliance with Bentelan specifications and serves as a tool for batch-level quality control.
Bentelan CoA mostly includes findings from lab analyses of a specific batch. For each Bentelan 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.
Bentelan may be tested according to a variety of international standards, such as European Pharmacopoeia (Bentelan EP), Bentelan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bentelan USP).
