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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
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Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Regulatory Info : Generic
Registration Country : India
Brand Name : Busoban
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
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PharmaCompass offers a list of Hyoscine Butyl Bromide 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 Hyoscine Butyl Bromide manufacturer or Hyoscine Butyl Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hyoscine Butyl Bromide manufacturer or Hyoscine Butyl Bromide supplier.
PharmaCompass also assists you with knowing the Hyoscine Butyl Bromide API Price utilized in the formulation of products. Hyoscine Butyl Bromide API Price is not always fixed or binding as the Hyoscine Butyl Bromide Price is obtained through a variety of data sources. The Hyoscine Butyl Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hyoscine Butylbromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyoscine Butylbromide, including repackagers and relabelers. The FDA regulates Hyoscine Butylbromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyoscine Butylbromide 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 Hyoscine Butylbromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyoscine Butylbromide supplier is an individual or a company that provides Hyoscine Butylbromide active pharmaceutical ingredient (API) or Hyoscine Butylbromide finished formulations upon request. The Hyoscine Butylbromide suppliers may include Hyoscine Butylbromide API manufacturers, exporters, distributors and traders.
click here to find a list of Hyoscine Butylbromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hyoscine Butylbromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyoscine Butylbromide active pharmaceutical ingredient (API) in detail. Different forms of Hyoscine Butylbromide DMFs exist exist since differing nations have different regulations, such as Hyoscine Butylbromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyoscine Butylbromide DMF submitted to regulatory agencies in the US is known as a USDMF. Hyoscine Butylbromide USDMF includes data on Hyoscine Butylbromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyoscine Butylbromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hyoscine Butylbromide 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 Hyoscine Butylbromide Drug Master File in Japan (Hyoscine Butylbromide JDMF) empowers Hyoscine Butylbromide 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 Hyoscine Butylbromide JDMF during the approval evaluation for pharmaceutical products. At the time of Hyoscine Butylbromide 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 Hyoscine Butylbromide 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 Hyoscine Butylbromide Drug Master File in Korea (Hyoscine Butylbromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hyoscine Butylbromide. The MFDS reviews the Hyoscine Butylbromide KDMF as part of the drug registration process and uses the information provided in the Hyoscine Butylbromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hyoscine Butylbromide 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 Hyoscine Butylbromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hyoscine Butylbromide suppliers with KDMF on PharmaCompass.
A Hyoscine Butylbromide CEP of the European Pharmacopoeia monograph is often referred to as a Hyoscine Butylbromide Certificate of Suitability (COS). The purpose of a Hyoscine Butylbromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hyoscine Butylbromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hyoscine Butylbromide to their clients by showing that a Hyoscine Butylbromide CEP has been issued for it. The manufacturer submits a Hyoscine Butylbromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hyoscine Butylbromide CEP holder for the record. Additionally, the data presented in the Hyoscine Butylbromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hyoscine Butylbromide DMF.
A Hyoscine Butylbromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hyoscine Butylbromide 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 Hyoscine Butylbromide suppliers with CEP (COS) on PharmaCompass.
A Hyoscine Butylbromide written confirmation (Hyoscine Butylbromide WC) is an official document issued by a regulatory agency to a Hyoscine Butylbromide manufacturer, verifying that the manufacturing facility of a Hyoscine Butylbromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hyoscine Butylbromide APIs or Hyoscine Butylbromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Hyoscine Butylbromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Hyoscine Butylbromide 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 Hyoscine Butylbromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hyoscine Butylbromide 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 Hyoscine Butylbromide 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 Hyoscine Butylbromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hyoscine Butylbromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hyoscine Butylbromide suppliers with NDC on PharmaCompass.
Hyoscine Butylbromide 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 Hyoscine Butylbromide 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 Hyoscine Butylbromide GMP manufacturer or Hyoscine Butylbromide GMP API supplier for your needs.
A Hyoscine Butylbromide CoA (Certificate of Analysis) is a formal document that attests to Hyoscine Butylbromide's compliance with Hyoscine Butylbromide specifications and serves as a tool for batch-level quality control.
Hyoscine Butylbromide CoA mostly includes findings from lab analyses of a specific batch. For each Hyoscine Butylbromide 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.
Hyoscine Butylbromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Hyoscine Butylbromide EP), Hyoscine Butylbromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hyoscine Butylbromide USP).
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