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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
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With Fermion, start the journey of your innovative API.
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Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Reliable Spanish CDMO Delivering High-Quality APIs and Intermediates with Excellence, Flexibility, and Regulatory Compliance.
Trusted Partner for Innovative, Sustainable, and High-Quality API Development and Production.
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USDMF
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API Imports and Exports
Drugs in Development
Lead Product(s) : Levosimendan
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Tenax Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Amendment to the existing agreement gives Tenax rights to develop and commercialize in the United States and Canada an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with PH-HFpEF, or other heart rel...
Product Name : ODM-109
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 15, 2020
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Regulatory Info :
Registration Country : Sweden
Brand Name : Simdax
Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION
Dosage Strength : 2.5 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Simdax
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 2.5 mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Simdax
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 2.5 mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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PharmaCompass offers a list of Levosimendan 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 Levosimendan manufacturer or Levosimendan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levosimendan manufacturer or Levosimendan supplier.
PharmaCompass also assists you with knowing the Levosimendan API Price utilized in the formulation of products. Levosimendan API Price is not always fixed or binding as the Levosimendan Price is obtained through a variety of data sources. The Levosimendan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Levosimendan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levosimendan, including repackagers and relabelers. The FDA regulates Levosimendan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levosimendan 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 Levosimendan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levosimendan supplier is an individual or a company that provides Levosimendan active pharmaceutical ingredient (API) or Levosimendan finished formulations upon request. The Levosimendan suppliers may include Levosimendan API manufacturers, exporters, distributors and traders.
click here to find a list of Levosimendan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levosimendan DMF (Drug Master File) is a document detailing the whole manufacturing process of Levosimendan active pharmaceutical ingredient (API) in detail. Different forms of Levosimendan DMFs exist exist since differing nations have different regulations, such as Levosimendan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levosimendan DMF submitted to regulatory agencies in the US is known as a USDMF. Levosimendan USDMF includes data on Levosimendan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levosimendan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levosimendan suppliers with USDMF on PharmaCompass.
A Levosimendan written confirmation (Levosimendan WC) is an official document issued by a regulatory agency to a Levosimendan manufacturer, verifying that the manufacturing facility of a Levosimendan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levosimendan APIs or Levosimendan finished pharmaceutical products to another nation, regulatory agencies frequently require a Levosimendan WC (written confirmation) as part of the regulatory process.
click here to find a list of Levosimendan suppliers with Written Confirmation (WC) on PharmaCompass.
Levosimendan 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 Levosimendan 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 Levosimendan GMP manufacturer or Levosimendan GMP API supplier for your needs.
A Levosimendan CoA (Certificate of Analysis) is a formal document that attests to Levosimendan's compliance with Levosimendan specifications and serves as a tool for batch-level quality control.
Levosimendan CoA mostly includes findings from lab analyses of a specific batch. For each Levosimendan 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.
Levosimendan may be tested according to a variety of international standards, such as European Pharmacopoeia (Levosimendan EP), Levosimendan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levosimendan USP).
