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CEP/COS
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JDMF
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KDMF
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-28
Pay. Date : 2020-02-24
DMF Number : 6868
Submission : 1987-01-20
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-17
DMF Number : 16053
Submission : 2002-06-27
Status :
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-21
Pay. Date : 2020-05-15
DMF Number : 4475
Submission : 1982-03-12
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
Minakem is manufacturing small molecules APIs including corticosteroids
About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 10MG/ML
USFDA APPLICATION NUMBER - 19386
DOSAGE - INJECTABLE;INJECTION - 1GM/100ML
USFDA APPLICATION NUMBER - 19386
DOSAGE - INJECTABLE;INJECTION - 2GM/100ML
USFDA APPLICATION NUMBER - 19386
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PharmaCompass offers a list of Esmolol 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 Esmolol Hydrochloride manufacturer or Esmolol Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Esmolol Hydrochloride manufacturer or Esmolol Hydrochloride supplier.
PharmaCompass also assists you with knowing the Esmolol Hydrochloride API Price utilized in the formulation of products. Esmolol Hydrochloride API Price is not always fixed or binding as the Esmolol Hydrochloride Price is obtained through a variety of data sources. The Esmolol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Esmolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esmolol, including repackagers and relabelers. The FDA regulates Esmolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esmolol 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 Esmolol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esmolol supplier is an individual or a company that provides Esmolol active pharmaceutical ingredient (API) or Esmolol finished formulations upon request. The Esmolol suppliers may include Esmolol API manufacturers, exporters, distributors and traders.
click here to find a list of Esmolol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Esmolol DMF (Drug Master File) is a document detailing the whole manufacturing process of Esmolol active pharmaceutical ingredient (API) in detail. Different forms of Esmolol DMFs exist exist since differing nations have different regulations, such as Esmolol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esmolol DMF submitted to regulatory agencies in the US is known as a USDMF. Esmolol USDMF includes data on Esmolol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esmolol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Esmolol suppliers with USDMF on PharmaCompass.
A Esmolol written confirmation (Esmolol WC) is an official document issued by a regulatory agency to a Esmolol manufacturer, verifying that the manufacturing facility of a Esmolol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Esmolol APIs or Esmolol finished pharmaceutical products to another nation, regulatory agencies frequently require a Esmolol WC (written confirmation) as part of the regulatory process.
click here to find a list of Esmolol 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 Esmolol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Esmolol 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 Esmolol 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 Esmolol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Esmolol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Esmolol suppliers with NDC on PharmaCompass.
Esmolol 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 Esmolol 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 Esmolol GMP manufacturer or Esmolol GMP API supplier for your needs.
A Esmolol CoA (Certificate of Analysis) is a formal document that attests to Esmolol's compliance with Esmolol specifications and serves as a tool for batch-level quality control.
Esmolol CoA mostly includes findings from lab analyses of a specific batch. For each Esmolol 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.
Esmolol may be tested according to a variety of international standards, such as European Pharmacopoeia (Esmolol EP), Esmolol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Esmolol USP).
