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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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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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AMI Lifesciences is Driven by Chemistry. Powered by People.
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Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
CAS Number : 56-91-7
End Use API : Tranexamic Acid
About The Company : Apex Healthcare Limited, established in 2002, is a trusted manufacturer and exporter of APIs, bulk drugs, and formulations, based in Ankleshwar, India’s large...
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DOSAGE - INJECTABLE;INJECTION - 100MG/ML
USFDA APPLICATION NUMBER - 19281
DOSAGE - TABLET;ORAL - 650MG
USFDA APPLICATION NUMBER - 22430
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ABOUT THIS PAGE
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PharmaCompass offers a list of Tranexamic Acid 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 Tranexamic Acid manufacturer or Tranexamic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tranexamic Acid manufacturer or Tranexamic Acid supplier.
PharmaCompass also assists you with knowing the Tranexamic Acid API Price utilized in the formulation of products. Tranexamic Acid API Price is not always fixed or binding as the Tranexamic Acid Price is obtained through a variety of data sources. The Tranexamic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tranexamic acid cis-form manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tranexamic acid cis-form, including repackagers and relabelers. The FDA regulates Tranexamic acid cis-form manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tranexamic acid cis-form 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 Tranexamic acid cis-form manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tranexamic acid cis-form supplier is an individual or a company that provides Tranexamic acid cis-form active pharmaceutical ingredient (API) or Tranexamic acid cis-form finished formulations upon request. The Tranexamic acid cis-form suppliers may include Tranexamic acid cis-form API manufacturers, exporters, distributors and traders.
click here to find a list of Tranexamic acid cis-form suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tranexamic acid cis-form DMF (Drug Master File) is a document detailing the whole manufacturing process of Tranexamic acid cis-form active pharmaceutical ingredient (API) in detail. Different forms of Tranexamic acid cis-form DMFs exist exist since differing nations have different regulations, such as Tranexamic acid cis-form USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tranexamic acid cis-form DMF submitted to regulatory agencies in the US is known as a USDMF. Tranexamic acid cis-form USDMF includes data on Tranexamic acid cis-form's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tranexamic acid cis-form USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tranexamic acid cis-form 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 Tranexamic acid cis-form Drug Master File in Japan (Tranexamic acid cis-form JDMF) empowers Tranexamic acid cis-form 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 Tranexamic acid cis-form JDMF during the approval evaluation for pharmaceutical products. At the time of Tranexamic acid cis-form 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 Tranexamic acid cis-form 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 Tranexamic acid cis-form Drug Master File in Korea (Tranexamic acid cis-form KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tranexamic acid cis-form. The MFDS reviews the Tranexamic acid cis-form KDMF as part of the drug registration process and uses the information provided in the Tranexamic acid cis-form KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tranexamic acid cis-form 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 Tranexamic acid cis-form API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tranexamic acid cis-form suppliers with KDMF on PharmaCompass.
A Tranexamic acid cis-form CEP of the European Pharmacopoeia monograph is often referred to as a Tranexamic acid cis-form Certificate of Suitability (COS). The purpose of a Tranexamic acid cis-form CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tranexamic acid cis-form EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tranexamic acid cis-form to their clients by showing that a Tranexamic acid cis-form CEP has been issued for it. The manufacturer submits a Tranexamic acid cis-form CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tranexamic acid cis-form CEP holder for the record. Additionally, the data presented in the Tranexamic acid cis-form CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tranexamic acid cis-form DMF.
A Tranexamic acid cis-form CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tranexamic acid cis-form 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 Tranexamic acid cis-form suppliers with CEP (COS) on PharmaCompass.
A Tranexamic acid cis-form written confirmation (Tranexamic acid cis-form WC) is an official document issued by a regulatory agency to a Tranexamic acid cis-form manufacturer, verifying that the manufacturing facility of a Tranexamic acid cis-form active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tranexamic acid cis-form APIs or Tranexamic acid cis-form finished pharmaceutical products to another nation, regulatory agencies frequently require a Tranexamic acid cis-form WC (written confirmation) as part of the regulatory process.
click here to find a list of Tranexamic acid cis-form 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 Tranexamic acid cis-form as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tranexamic acid cis-form 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 Tranexamic acid cis-form 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 Tranexamic acid cis-form and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tranexamic acid cis-form NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tranexamic acid cis-form suppliers with NDC on PharmaCompass.
Tranexamic acid cis-form 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 Tranexamic acid cis-form 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 Tranexamic acid cis-form GMP manufacturer or Tranexamic acid cis-form GMP API supplier for your needs.
A Tranexamic acid cis-form CoA (Certificate of Analysis) is a formal document that attests to Tranexamic acid cis-form's compliance with Tranexamic acid cis-form specifications and serves as a tool for batch-level quality control.
Tranexamic acid cis-form CoA mostly includes findings from lab analyses of a specific batch. For each Tranexamic acid cis-form 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.
Tranexamic acid cis-form may be tested according to a variety of international standards, such as European Pharmacopoeia (Tranexamic acid cis-form EP), Tranexamic acid cis-form JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tranexamic acid cis-form USP).
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