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API SUPPLIERS
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USDMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-23
Pay. Date : 2017-05-09
DMF Number : 23554
Submission : 2010-02-21
Status :
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-19
Pay. Date : 2024-01-22
DMF Number : 39123
Submission : 2024-01-29
Status :
Type : II
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-14
Pay. Date : 2020-04-09
DMF Number : 24999
Submission : 2011-05-30
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 : 23130
Submission : 2009-09-28
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Cisatracurium Besilate, Process B
Certificate Number : CEP 2023-465 - Rev 01
Status : Valid
Issue Date : 2024-10-24
Type : Chemical
Substance Number : 2763
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Certificate Number : CEP 2016-200 - Rev 01
Status : Valid
Issue Date : 2024-10-23
Type : Chemical
Substance Number : 2763
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Certificate Number : R1-CEP 2016-285 - Rev 00
Status : Valid
Issue Date : 2022-09-26
Type : Chemical
Substance Number : 2763
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : R1-CEP 2016-093 - Rev 00
Status : Valid
Issue Date : 2022-05-16
Type : Chemical
Substance Number : 2763
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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 ...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
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, ...
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...
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...
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Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Solution For Injection
Dosage Strength : 2MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Solution For Injection
Dosage Strength : 5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
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DOSAGE - INJECTABLE;INJECTION - EQ 10MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20551
DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20551
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PharmaCompass offers a list of Cisatracurium Besylate 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 Cisatracurium Besylate manufacturer or Cisatracurium Besylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cisatracurium Besylate manufacturer or Cisatracurium Besylate supplier.
PharmaCompass also assists you with knowing the Cisatracurium Besylate API Price utilized in the formulation of products. Cisatracurium Besylate API Price is not always fixed or binding as the Cisatracurium Besylate Price is obtained through a variety of data sources. The Cisatracurium Besylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cisatracurium Besylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cisatracurium Besylate, including repackagers and relabelers. The FDA regulates Cisatracurium Besylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cisatracurium Besylate 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 Cisatracurium Besylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cisatracurium Besylate supplier is an individual or a company that provides Cisatracurium Besylate active pharmaceutical ingredient (API) or Cisatracurium Besylate finished formulations upon request. The Cisatracurium Besylate suppliers may include Cisatracurium Besylate API manufacturers, exporters, distributors and traders.
click here to find a list of Cisatracurium Besylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cisatracurium Besylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cisatracurium Besylate active pharmaceutical ingredient (API) in detail. Different forms of Cisatracurium Besylate DMFs exist exist since differing nations have different regulations, such as Cisatracurium Besylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cisatracurium Besylate DMF submitted to regulatory agencies in the US is known as a USDMF. Cisatracurium Besylate USDMF includes data on Cisatracurium Besylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cisatracurium Besylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cisatracurium Besylate suppliers with USDMF on PharmaCompass.
A Cisatracurium Besylate CEP of the European Pharmacopoeia monograph is often referred to as a Cisatracurium Besylate Certificate of Suitability (COS). The purpose of a Cisatracurium Besylate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cisatracurium Besylate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cisatracurium Besylate to their clients by showing that a Cisatracurium Besylate CEP has been issued for it. The manufacturer submits a Cisatracurium Besylate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cisatracurium Besylate CEP holder for the record. Additionally, the data presented in the Cisatracurium Besylate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cisatracurium Besylate DMF.
A Cisatracurium Besylate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cisatracurium Besylate 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 Cisatracurium Besylate suppliers with CEP (COS) on PharmaCompass.
A Cisatracurium Besylate written confirmation (Cisatracurium Besylate WC) is an official document issued by a regulatory agency to a Cisatracurium Besylate manufacturer, verifying that the manufacturing facility of a Cisatracurium Besylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cisatracurium Besylate APIs or Cisatracurium Besylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Cisatracurium Besylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Cisatracurium Besylate 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 Cisatracurium Besylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cisatracurium Besylate 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 Cisatracurium Besylate 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 Cisatracurium Besylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cisatracurium Besylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cisatracurium Besylate suppliers with NDC on PharmaCompass.
Cisatracurium Besylate 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 Cisatracurium Besylate 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 Cisatracurium Besylate GMP manufacturer or Cisatracurium Besylate GMP API supplier for your needs.
A Cisatracurium Besylate CoA (Certificate of Analysis) is a formal document that attests to Cisatracurium Besylate's compliance with Cisatracurium Besylate specifications and serves as a tool for batch-level quality control.
Cisatracurium Besylate CoA mostly includes findings from lab analyses of a specific batch. For each Cisatracurium Besylate 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.
Cisatracurium Besylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cisatracurium Besylate EP), Cisatracurium Besylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cisatracurium Besylate USP).
