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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Tramazoline Hydrochloride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tramazoline Hydrochloride Monohydrate, including repackagers and relabelers. The FDA regulates Tramazoline Hydrochloride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tramazoline Hydrochloride Monohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Tramazoline Hydrochloride Monohydrate supplier is an individual or a company that provides Tramazoline Hydrochloride Monohydrate active pharmaceutical ingredient (API) or Tramazoline Hydrochloride Monohydrate finished formulations upon request. The Tramazoline Hydrochloride Monohydrate suppliers may include Tramazoline Hydrochloride Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Tramazoline Hydrochloride Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Tramazoline Hydrochloride Monohydrate Drug Master File in Japan (Tramazoline Hydrochloride Monohydrate JDMF) empowers Tramazoline Hydrochloride Monohydrate 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 Tramazoline Hydrochloride Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Tramazoline Hydrochloride Monohydrate 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 Tramazoline Hydrochloride Monohydrate suppliers with JDMF on PharmaCompass.
A Tramazoline Hydrochloride Monohydrate CEP of the European Pharmacopoeia monograph is often referred to as a Tramazoline Hydrochloride Monohydrate Certificate of Suitability (COS). The purpose of a Tramazoline Hydrochloride Monohydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tramazoline Hydrochloride Monohydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tramazoline Hydrochloride Monohydrate to their clients by showing that a Tramazoline Hydrochloride Monohydrate CEP has been issued for it. The manufacturer submits a Tramazoline Hydrochloride Monohydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tramazoline Hydrochloride Monohydrate CEP holder for the record. Additionally, the data presented in the Tramazoline Hydrochloride Monohydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tramazoline Hydrochloride Monohydrate DMF.
A Tramazoline Hydrochloride Monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tramazoline Hydrochloride Monohydrate 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 Tramazoline Hydrochloride Monohydrate suppliers with CEP (COS) on PharmaCompass.
Tramazoline Hydrochloride Monohydrate 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 Tramazoline Hydrochloride Monohydrate 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 Tramazoline Hydrochloride Monohydrate GMP manufacturer or Tramazoline Hydrochloride Monohydrate GMP API supplier for your needs.
A Tramazoline Hydrochloride Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Tramazoline Hydrochloride Monohydrate's compliance with Tramazoline Hydrochloride Monohydrate specifications and serves as a tool for batch-level quality control.
Tramazoline Hydrochloride Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Tramazoline Hydrochloride Monohydrate 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.
Tramazoline Hydrochloride Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tramazoline Hydrochloride Monohydrate EP), Tramazoline Hydrochloride Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tramazoline Hydrochloride Monohydrate USP).
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