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