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API SUPPLIERS
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API™
CEP/COS
JDMF
NDC
ASMF, CN
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
EU DMF
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
CEP/COS
JDMF
NDC
KDMF
CN, RU
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
BR, ASMF
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
KDMF
CN, RU
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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USDMF
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-14
DMF Number : 9854
Submission : 1992-09-01
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19572
Submission : 2006-06-29
Status :
Type : II
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-27
DMF Number : 19819
Submission : 2006-09-15
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 20068
Submission : 2006-12-20
Status :
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37698
Submission : 2023-01-05
Status :
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-24
Pay. Date : 2024-04-08
DMF Number : 39437
Submission : 2024-03-28
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. AP...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Aspen API. More than just an API™
About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
About the Company : Farmhispania Group comprises two companies in Spain: Farmhispania in Barcelona and Rolabo in Zaragoza. Since its inception, the group has consistently invested in advanced equipmen...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...
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
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Suanfarma, at the Core of a Better Life.
CAS Number : 119302-19-1
End Use API : Rocuronium Bromide
About The Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the ...
Suanfarma, at the Core of a Better Life.
CAS Number : 119302-20-4
End Use API : Rocuronium Bromide
About The Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the ...
Suanfarma, at the Core of a Better Life.
CAS Number : 119302-24-8
End Use API : Rocuronium Bromide
About The Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the ...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
(2b,3a,5a,16b,17b)-17-Acetoxy-3-hydroxy-2-(4-morph...
CAS Number : 119302-24-8
End Use API : Rocuronium Bromide
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
(2b,3a,5a,16b,17b)-2-(4-Morpholinyl)-16-(1-pyrroli...
CAS Number : 119302-20-4
End Use API : Rocuronium Bromide
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
2a,3a,16a,17a-Diepoxy-17b-acetoxy-5a-androstane
CAS Number : 50588-22-2
End Use API : Rocuronium Bromide
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
2,16-Dipiperidin-1-ylandrosta-3,17-diol
CAS Number : 13522-16-2
End Use API : Rocuronium Bromide
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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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 - 100MG/10ML (1...DOSAGE - INJECTABLE;INJECTION - 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20214
DOSAGE - INJECTABLE;INJECTION - 10MG/ML (10MG...DOSAGE - INJECTABLE;INJECTION - 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20214
DOSAGE - INJECTABLE;INJECTION - 50MG/5ML (10M...DOSAGE - INJECTABLE;INJECTION - 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20214
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Rocuronium 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 Rocuronium Bromide manufacturer or Rocuronium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rocuronium Bromide manufacturer or Rocuronium Bromide supplier.
PharmaCompass also assists you with knowing the Rocuronium Bromide API Price utilized in the formulation of products. Rocuronium Bromide API Price is not always fixed or binding as the Rocuronium Bromide Price is obtained through a variety of data sources. The Rocuronium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Esmeron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esmeron, including repackagers and relabelers. The FDA regulates Esmeron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esmeron 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 Esmeron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esmeron supplier is an individual or a company that provides Esmeron active pharmaceutical ingredient (API) or Esmeron finished formulations upon request. The Esmeron suppliers may include Esmeron API manufacturers, exporters, distributors and traders.
click here to find a list of Esmeron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Esmeron DMF (Drug Master File) is a document detailing the whole manufacturing process of Esmeron active pharmaceutical ingredient (API) in detail. Different forms of Esmeron DMFs exist exist since differing nations have different regulations, such as Esmeron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Esmeron DMF submitted to regulatory agencies in the US is known as a USDMF. Esmeron USDMF includes data on Esmeron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Esmeron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Esmeron 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 Esmeron Drug Master File in Japan (Esmeron JDMF) empowers Esmeron 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 Esmeron JDMF during the approval evaluation for pharmaceutical products. At the time of Esmeron 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 Esmeron 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 Esmeron Drug Master File in Korea (Esmeron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esmeron. The MFDS reviews the Esmeron KDMF as part of the drug registration process and uses the information provided in the Esmeron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Esmeron 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 Esmeron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Esmeron suppliers with KDMF on PharmaCompass.
A Esmeron CEP of the European Pharmacopoeia monograph is often referred to as a Esmeron Certificate of Suitability (COS). The purpose of a Esmeron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Esmeron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Esmeron to their clients by showing that a Esmeron CEP has been issued for it. The manufacturer submits a Esmeron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Esmeron CEP holder for the record. Additionally, the data presented in the Esmeron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Esmeron DMF.
A Esmeron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Esmeron 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 Esmeron suppliers with CEP (COS) on PharmaCompass.
A Esmeron written confirmation (Esmeron WC) is an official document issued by a regulatory agency to a Esmeron manufacturer, verifying that the manufacturing facility of a Esmeron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Esmeron APIs or Esmeron finished pharmaceutical products to another nation, regulatory agencies frequently require a Esmeron WC (written confirmation) as part of the regulatory process.
click here to find a list of Esmeron 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 Esmeron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Esmeron 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 Esmeron 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 Esmeron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Esmeron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Esmeron suppliers with NDC on PharmaCompass.
Esmeron 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 Esmeron 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 Esmeron GMP manufacturer or Esmeron GMP API supplier for your needs.
A Esmeron CoA (Certificate of Analysis) is a formal document that attests to Esmeron's compliance with Esmeron specifications and serves as a tool for batch-level quality control.
Esmeron CoA mostly includes findings from lab analyses of a specific batch. For each Esmeron 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.
Esmeron may be tested according to a variety of international standards, such as European Pharmacopoeia (Esmeron EP), Esmeron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Esmeron USP).
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