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