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API SUPPLIERS
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Faran Shimi Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Estramustine Phosphate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estramustine Phosphate Sodium, including repackagers and relabelers. The FDA regulates Estramustine Phosphate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium supplier is an individual or a company that provides Estramustine Phosphate Sodium active pharmaceutical ingredient (API) or Estramustine Phosphate Sodium finished formulations upon request. The Estramustine Phosphate Sodium suppliers may include Estramustine Phosphate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Estramustine Phosphate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estramustine Phosphate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Estramustine Phosphate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Estramustine Phosphate Sodium DMFs exist exist since differing nations have different regulations, such as Estramustine Phosphate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estramustine Phosphate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Estramustine Phosphate Sodium USDMF includes data on Estramustine Phosphate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estramustine Phosphate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium Drug Master File in Japan (Estramustine Phosphate Sodium JDMF) empowers Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium suppliers with JDMF on PharmaCompass.
A Estramustine Phosphate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Estramustine Phosphate Sodium Certificate of Suitability (COS). The purpose of a Estramustine Phosphate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Estramustine Phosphate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Estramustine Phosphate Sodium to their clients by showing that a Estramustine Phosphate Sodium CEP has been issued for it. The manufacturer submits a Estramustine Phosphate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Estramustine Phosphate Sodium CEP holder for the record. Additionally, the data presented in the Estramustine Phosphate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Estramustine Phosphate Sodium DMF.
A Estramustine Phosphate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium suppliers with CEP (COS) on PharmaCompass.
Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium GMP manufacturer or Estramustine Phosphate Sodium GMP API supplier for your needs.
A Estramustine Phosphate Sodium CoA (Certificate of Analysis) is a formal document that attests to Estramustine Phosphate Sodium's compliance with Estramustine Phosphate Sodium specifications and serves as a tool for batch-level quality control.
Estramustine Phosphate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Estramustine Phosphate Sodium 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.
Estramustine Phosphate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Estramustine Phosphate Sodium EP), Estramustine Phosphate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Estramustine Phosphate Sodium USP).
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