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