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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Disintegrants & Superdisintegrants
Lubricants & Glidants
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Rheology Modifiers
Controlled & Modified Release
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
A Estradiol Benzoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Benzoate, including repackagers and relabelers. The FDA regulates Estradiol Benzoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Benzoate 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 Estradiol Benzoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estradiol Benzoate supplier is an individual or a company that provides Estradiol Benzoate active pharmaceutical ingredient (API) or Estradiol Benzoate finished formulations upon request. The Estradiol Benzoate suppliers may include Estradiol Benzoate API manufacturers, exporters, distributors and traders.
click here to find a list of Estradiol Benzoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estradiol Benzoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Estradiol Benzoate active pharmaceutical ingredient (API) in detail. Different forms of Estradiol Benzoate DMFs exist exist since differing nations have different regulations, such as Estradiol Benzoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estradiol Benzoate DMF submitted to regulatory agencies in the US is known as a USDMF. Estradiol Benzoate USDMF includes data on Estradiol Benzoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estradiol Benzoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estradiol Benzoate suppliers with USDMF on PharmaCompass.
A Estradiol Benzoate CEP of the European Pharmacopoeia monograph is often referred to as a Estradiol Benzoate Certificate of Suitability (COS). The purpose of a Estradiol Benzoate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Estradiol Benzoate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Estradiol Benzoate to their clients by showing that a Estradiol Benzoate CEP has been issued for it. The manufacturer submits a Estradiol Benzoate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Estradiol Benzoate CEP holder for the record. Additionally, the data presented in the Estradiol Benzoate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Estradiol Benzoate DMF.
A Estradiol Benzoate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Estradiol Benzoate 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 Estradiol Benzoate suppliers with CEP (COS) 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 Estradiol Benzoate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Estradiol Benzoate 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 Estradiol Benzoate 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 Estradiol Benzoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Estradiol Benzoate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Estradiol Benzoate suppliers with NDC on PharmaCompass.
Estradiol Benzoate 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 Estradiol Benzoate 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 Estradiol Benzoate GMP manufacturer or Estradiol Benzoate GMP API supplier for your needs.
A Estradiol Benzoate CoA (Certificate of Analysis) is a formal document that attests to Estradiol Benzoate's compliance with Estradiol Benzoate specifications and serves as a tool for batch-level quality control.
Estradiol Benzoate CoA mostly includes findings from lab analyses of a specific batch. For each Estradiol Benzoate 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.
Estradiol Benzoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Estradiol Benzoate EP), Estradiol Benzoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Estradiol Benzoate USP).
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