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