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API SUPPLIERS
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USDMF
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EUROAPI
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ABOUT THIS PAGE
69
PharmaCompass offers a list of Scopolamine Hydrobromide 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 Scopolamine Hydrobromide manufacturer or Scopolamine Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Scopolamine Hydrobromide manufacturer or Scopolamine Hydrobromide supplier.
PharmaCompass also assists you with knowing the Scopolamine Hydrobromide API Price utilized in the formulation of products. Scopolamine Hydrobromide API Price is not always fixed or binding as the Scopolamine Hydrobromide Price is obtained through a variety of data sources. The Scopolamine Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hyoscine HBr manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyoscine HBr, including repackagers and relabelers. The FDA regulates Hyoscine HBr manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyoscine HBr 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 HBr manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyoscine HBr supplier is an individual or a company that provides Hyoscine HBr active pharmaceutical ingredient (API) or Hyoscine HBr finished formulations upon request. The Hyoscine HBr suppliers may include Hyoscine HBr API manufacturers, exporters, distributors and traders.
click here to find a list of Hyoscine HBr suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hyoscine HBr DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyoscine HBr active pharmaceutical ingredient (API) in detail. Different forms of Hyoscine HBr DMFs exist exist since differing nations have different regulations, such as Hyoscine HBr USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyoscine HBr DMF submitted to regulatory agencies in the US is known as a USDMF. Hyoscine HBr USDMF includes data on Hyoscine HBr's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyoscine HBr USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hyoscine HBr 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 HBr Drug Master File in Japan (Hyoscine HBr JDMF) empowers Hyoscine HBr 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 HBr JDMF during the approval evaluation for pharmaceutical products. At the time of Hyoscine HBr 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 HBr suppliers with JDMF on PharmaCompass.
A Hyoscine HBr CEP of the European Pharmacopoeia monograph is often referred to as a Hyoscine HBr Certificate of Suitability (COS). The purpose of a Hyoscine HBr CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hyoscine HBr EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hyoscine HBr to their clients by showing that a Hyoscine HBr CEP has been issued for it. The manufacturer submits a Hyoscine HBr CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hyoscine HBr CEP holder for the record. Additionally, the data presented in the Hyoscine HBr CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hyoscine HBr DMF.
A Hyoscine HBr CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hyoscine HBr 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 HBr suppliers with CEP (COS) on PharmaCompass.
A Hyoscine HBr written confirmation (Hyoscine HBr WC) is an official document issued by a regulatory agency to a Hyoscine HBr manufacturer, verifying that the manufacturing facility of a Hyoscine HBr active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hyoscine HBr APIs or Hyoscine HBr finished pharmaceutical products to another nation, regulatory agencies frequently require a Hyoscine HBr WC (written confirmation) as part of the regulatory process.
click here to find a list of Hyoscine HBr 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 HBr as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hyoscine HBr 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 HBr 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 HBr and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hyoscine HBr NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hyoscine HBr suppliers with NDC on PharmaCompass.
Hyoscine HBr 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 HBr 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 HBr GMP manufacturer or Hyoscine HBr GMP API supplier for your needs.
A Hyoscine HBr CoA (Certificate of Analysis) is a formal document that attests to Hyoscine HBr's compliance with Hyoscine HBr specifications and serves as a tool for batch-level quality control.
Hyoscine HBr CoA mostly includes findings from lab analyses of a specific batch. For each Hyoscine HBr 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 HBr may be tested according to a variety of international standards, such as European Pharmacopoeia (Hyoscine HBr EP), Hyoscine HBr JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hyoscine HBr USP).
