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