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KDMF
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Canada
DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Gangwal Healthcare
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
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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, 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.
A SPIRIVA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SPIRIVA, including repackagers and relabelers. The FDA regulates SPIRIVA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SPIRIVA 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 SPIRIVA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A SPIRIVA supplier is an individual or a company that provides SPIRIVA active pharmaceutical ingredient (API) or SPIRIVA finished formulations upon request. The SPIRIVA suppliers may include SPIRIVA API manufacturers, exporters, distributors and traders.
click here to find a list of SPIRIVA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A SPIRIVA DMF (Drug Master File) is a document detailing the whole manufacturing process of SPIRIVA active pharmaceutical ingredient (API) in detail. Different forms of SPIRIVA DMFs exist exist since differing nations have different regulations, such as SPIRIVA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SPIRIVA DMF submitted to regulatory agencies in the US is known as a USDMF. SPIRIVA USDMF includes data on SPIRIVA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SPIRIVA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SPIRIVA 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 SPIRIVA Drug Master File in Japan (SPIRIVA JDMF) empowers SPIRIVA 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 SPIRIVA JDMF during the approval evaluation for pharmaceutical products. At the time of SPIRIVA 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 SPIRIVA suppliers with JDMF on PharmaCompass.
A SPIRIVA CEP of the European Pharmacopoeia monograph is often referred to as a SPIRIVA Certificate of Suitability (COS). The purpose of a SPIRIVA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SPIRIVA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SPIRIVA to their clients by showing that a SPIRIVA CEP has been issued for it. The manufacturer submits a SPIRIVA CEP (COS) as part of the market authorization procedure, and it takes on the role of a SPIRIVA CEP holder for the record. Additionally, the data presented in the SPIRIVA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SPIRIVA DMF.
A SPIRIVA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SPIRIVA 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 SPIRIVA suppliers with CEP (COS) on PharmaCompass.
A SPIRIVA written confirmation (SPIRIVA WC) is an official document issued by a regulatory agency to a SPIRIVA manufacturer, verifying that the manufacturing facility of a SPIRIVA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SPIRIVA APIs or SPIRIVA finished pharmaceutical products to another nation, regulatory agencies frequently require a SPIRIVA WC (written confirmation) as part of the regulatory process.
click here to find a list of SPIRIVA 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 SPIRIVA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SPIRIVA 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 SPIRIVA 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 SPIRIVA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SPIRIVA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SPIRIVA suppliers with NDC on PharmaCompass.
SPIRIVA 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 SPIRIVA GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right SPIRIVA GMP manufacturer or SPIRIVA GMP API supplier for your needs.
A SPIRIVA CoA (Certificate of Analysis) is a formal document that attests to SPIRIVA's compliance with SPIRIVA specifications and serves as a tool for batch-level quality control.
SPIRIVA CoA mostly includes findings from lab analyses of a specific batch. For each SPIRIVA 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.
SPIRIVA may be tested according to a variety of international standards, such as European Pharmacopoeia (SPIRIVA EP), SPIRIVA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SPIRIVA USP).
