Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Click Us!
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Jai Radhe Sales is your partner for all your sourcing needs.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Parenteral
Fillers, Diluents & Binders
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Dobutamine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dobutamine Hydrochloride, including repackagers and relabelers. The FDA regulates Dobutamine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dobutamine 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 Dobutamine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dobutamine Hydrochloride supplier is an individual or a company that provides Dobutamine Hydrochloride active pharmaceutical ingredient (API) or Dobutamine Hydrochloride finished formulations upon request. The Dobutamine Hydrochloride suppliers may include Dobutamine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dobutamine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dobutamine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dobutamine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dobutamine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dobutamine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dobutamine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dobutamine Hydrochloride USDMF includes data on Dobutamine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dobutamine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dobutamine 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 Dobutamine Hydrochloride Drug Master File in Japan (Dobutamine Hydrochloride JDMF) empowers Dobutamine 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 Dobutamine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Dobutamine 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 Dobutamine Hydrochloride 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 Hydrochloride Drug Master File in Korea (Dobutamine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dobutamine Hydrochloride. The MFDS reviews the Dobutamine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Dobutamine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dobutamine Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dobutamine Hydrochloride suppliers with KDMF on PharmaCompass.
A Dobutamine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Dobutamine Hydrochloride Certificate of Suitability (COS). The purpose of a Dobutamine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dobutamine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dobutamine Hydrochloride to their clients by showing that a Dobutamine Hydrochloride CEP has been issued for it. The manufacturer submits a Dobutamine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dobutamine Hydrochloride CEP holder for the record. Additionally, the data presented in the Dobutamine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dobutamine Hydrochloride DMF.
A Dobutamine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dobutamine 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 Dobutamine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Dobutamine Hydrochloride written confirmation (Dobutamine Hydrochloride WC) is an official document issued by a regulatory agency to a Dobutamine Hydrochloride manufacturer, verifying that the manufacturing facility of a Dobutamine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dobutamine Hydrochloride APIs or Dobutamine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Dobutamine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Dobutamine 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 Dobutamine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dobutamine 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 Dobutamine 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 Dobutamine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dobutamine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dobutamine Hydrochloride suppliers with NDC on PharmaCompass.
Dobutamine 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 Dobutamine 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 Dobutamine Hydrochloride GMP manufacturer or Dobutamine Hydrochloride GMP API supplier for your needs.
A Dobutamine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Dobutamine Hydrochloride's compliance with Dobutamine Hydrochloride specifications and serves as a tool for batch-level quality control.
Dobutamine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Dobutamine 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.
Dobutamine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Dobutamine Hydrochloride EP), Dobutamine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dobutamine Hydrochloride USP).
LOOKING FOR A SUPPLIER?
