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