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API SUPPLIERS
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USDMF
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DOSAGE - SPRAY, METERED;NASAL - 0.021MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20393
DOSAGE - SPRAY, METERED;NASAL - 0.042MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20394
DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20950
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PharmaCompass offers a list of Ipratropium 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 Ipratropium Bromide manufacturer or Ipratropium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ipratropium Bromide manufacturer or Ipratropium Bromide supplier.
PharmaCompass also assists you with knowing the Ipratropium Bromide API Price utilized in the formulation of products. Ipratropium Bromide API Price is not always fixed or binding as the Ipratropium Bromide Price is obtained through a variety of data sources. The Ipratropium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ipratropium Bromide, (exo,syn)-Isomer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ipratropium Bromide, (exo,syn)-Isomer, including repackagers and relabelers. The FDA regulates Ipratropium Bromide, (exo,syn)-Isomer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ipratropium Bromide, (exo,syn)-Isomer supplier is an individual or a company that provides Ipratropium Bromide, (exo,syn)-Isomer active pharmaceutical ingredient (API) or Ipratropium Bromide, (exo,syn)-Isomer finished formulations upon request. The Ipratropium Bromide, (exo,syn)-Isomer suppliers may include Ipratropium Bromide, (exo,syn)-Isomer API manufacturers, exporters, distributors and traders.
click here to find a list of Ipratropium Bromide, (exo,syn)-Isomer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ipratropium Bromide, (exo,syn)-Isomer DMF (Drug Master File) is a document detailing the whole manufacturing process of Ipratropium Bromide, (exo,syn)-Isomer active pharmaceutical ingredient (API) in detail. Different forms of Ipratropium Bromide, (exo,syn)-Isomer DMFs exist exist since differing nations have different regulations, such as Ipratropium Bromide, (exo,syn)-Isomer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ipratropium Bromide, (exo,syn)-Isomer DMF submitted to regulatory agencies in the US is known as a USDMF. Ipratropium Bromide, (exo,syn)-Isomer USDMF includes data on Ipratropium Bromide, (exo,syn)-Isomer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ipratropium Bromide, (exo,syn)-Isomer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer Drug Master File in Japan (Ipratropium Bromide, (exo,syn)-Isomer JDMF) empowers Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer JDMF during the approval evaluation for pharmaceutical products. At the time of Ipratropium Bromide, (exo,syn)-Isomer JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ipratropium Bromide, (exo,syn)-Isomer Drug Master File in Korea (Ipratropium Bromide, (exo,syn)-Isomer KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ipratropium Bromide, (exo,syn)-Isomer. The MFDS reviews the Ipratropium Bromide, (exo,syn)-Isomer KDMF as part of the drug registration process and uses the information provided in the Ipratropium Bromide, (exo,syn)-Isomer KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer API can apply through the Korea Drug Master File (KDMF).
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A Ipratropium Bromide, (exo,syn)-Isomer CEP of the European Pharmacopoeia monograph is often referred to as a Ipratropium Bromide, (exo,syn)-Isomer Certificate of Suitability (COS). The purpose of a Ipratropium Bromide, (exo,syn)-Isomer CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ipratropium Bromide, (exo,syn)-Isomer EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ipratropium Bromide, (exo,syn)-Isomer to their clients by showing that a Ipratropium Bromide, (exo,syn)-Isomer CEP has been issued for it. The manufacturer submits a Ipratropium Bromide, (exo,syn)-Isomer CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ipratropium Bromide, (exo,syn)-Isomer CEP holder for the record. Additionally, the data presented in the Ipratropium Bromide, (exo,syn)-Isomer CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ipratropium Bromide, (exo,syn)-Isomer DMF.
A Ipratropium Bromide, (exo,syn)-Isomer CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer suppliers with CEP (COS) on PharmaCompass.
A Ipratropium Bromide, (exo,syn)-Isomer written confirmation (Ipratropium Bromide, (exo,syn)-Isomer WC) is an official document issued by a regulatory agency to a Ipratropium Bromide, (exo,syn)-Isomer manufacturer, verifying that the manufacturing facility of a Ipratropium Bromide, (exo,syn)-Isomer active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ipratropium Bromide, (exo,syn)-Isomer APIs or Ipratropium Bromide, (exo,syn)-Isomer finished pharmaceutical products to another nation, regulatory agencies frequently require a Ipratropium Bromide, (exo,syn)-Isomer WC (written confirmation) as part of the regulatory process.
click here to find a list of Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ipratropium Bromide, (exo,syn)-Isomer NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ipratropium Bromide, (exo,syn)-Isomer suppliers with NDC on PharmaCompass.
Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer 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 Ipratropium Bromide, (exo,syn)-Isomer GMP manufacturer or Ipratropium Bromide, (exo,syn)-Isomer GMP API supplier for your needs.
A Ipratropium Bromide, (exo,syn)-Isomer CoA (Certificate of Analysis) is a formal document that attests to Ipratropium Bromide, (exo,syn)-Isomer's compliance with Ipratropium Bromide, (exo,syn)-Isomer specifications and serves as a tool for batch-level quality control.
Ipratropium Bromide, (exo,syn)-Isomer CoA mostly includes findings from lab analyses of a specific batch. For each Ipratropium Bromide, (exo,syn)-Isomer 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.
Ipratropium Bromide, (exo,syn)-Isomer may be tested according to a variety of international standards, such as European Pharmacopoeia (Ipratropium Bromide, (exo,syn)-Isomer EP), Ipratropium Bromide, (exo,syn)-Isomer JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ipratropium Bromide, (exo,syn)-Isomer USP).
