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API SUPPLIERS
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Tyrothricin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tyrothricin, including repackagers and relabelers. The FDA regulates Tyrothricin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tyrothricin 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 Tyrothricin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tyrothricin supplier is an individual or a company that provides Tyrothricin active pharmaceutical ingredient (API) or Tyrothricin finished formulations upon request. The Tyrothricin suppliers may include Tyrothricin API manufacturers, exporters, distributors and traders.
click here to find a list of Tyrothricin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tyrothricin DMF (Drug Master File) is a document detailing the whole manufacturing process of Tyrothricin active pharmaceutical ingredient (API) in detail. Different forms of Tyrothricin DMFs exist exist since differing nations have different regulations, such as Tyrothricin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tyrothricin DMF submitted to regulatory agencies in the US is known as a USDMF. Tyrothricin USDMF includes data on Tyrothricin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tyrothricin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tyrothricin suppliers with USDMF on PharmaCompass.
A Tyrothricin CEP of the European Pharmacopoeia monograph is often referred to as a Tyrothricin Certificate of Suitability (COS). The purpose of a Tyrothricin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tyrothricin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tyrothricin to their clients by showing that a Tyrothricin CEP has been issued for it. The manufacturer submits a Tyrothricin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tyrothricin CEP holder for the record. Additionally, the data presented in the Tyrothricin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tyrothricin DMF.
A Tyrothricin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tyrothricin 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 Tyrothricin suppliers with CEP (COS) on PharmaCompass.
Tyrothricin 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 Tyrothricin 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 Tyrothricin GMP manufacturer or Tyrothricin GMP API supplier for your needs.
A Tyrothricin CoA (Certificate of Analysis) is a formal document that attests to Tyrothricin's compliance with Tyrothricin specifications and serves as a tool for batch-level quality control.
Tyrothricin CoA mostly includes findings from lab analyses of a specific batch. For each Tyrothricin 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.
Tyrothricin may be tested according to a variety of international standards, such as European Pharmacopoeia (Tyrothricin EP), Tyrothricin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tyrothricin USP).
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