Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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API
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FDF
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
EDQM
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USP
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JP
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Others
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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INSERT, EXTENDED RELEASE;VAGINAL - E...DOSAGE - INSERT, EXTENDED RELEASE;VAGINAL - EQ 0.05MG BASE/24HR
USFDA APPLICATION NUMBER - 21367
DOSAGE - INSERT, EXTENDED RELEASE;VAGINAL - E...DOSAGE - INSERT, EXTENDED RELEASE;VAGINAL - EQ 0.1MG BASE/24HR
USFDA APPLICATION NUMBER - 21367
Related Excipient Companies
SPI Pharma
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]Direct Compression
Lubricants & Glidants
Emulsifying Agents
Co-Processed Excipients
Fillers, Diluents & Binders
Thickeners and Stabilizers
API Stability Enhancers
Controlled & Modified Release
Digital Content
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Global Sales Information
ANALYTICAL
ABOUT THIS PAGE
A Estradiol Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Acetate, including repackagers and relabelers. The FDA regulates Estradiol Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Acetate 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 Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estradiol Acetate supplier is an individual or a company that provides Estradiol Acetate active pharmaceutical ingredient (API) or Estradiol Acetate finished formulations upon request. The Estradiol Acetate suppliers may include Estradiol Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Estradiol Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estradiol Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Estradiol Acetate active pharmaceutical ingredient (API) in detail. Different forms of Estradiol Acetate DMFs exist exist since differing nations have different regulations, such as Estradiol Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estradiol Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Estradiol Acetate USDMF includes data on Estradiol Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estradiol Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estradiol Acetate suppliers with USDMF 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 Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Estradiol Acetate 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 Acetate 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 Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Estradiol Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Estradiol Acetate suppliers with NDC on PharmaCompass.
Estradiol Acetate 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 Acetate 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 Acetate GMP manufacturer or Estradiol Acetate GMP API supplier for your needs.
A Estradiol Acetate CoA (Certificate of Analysis) is a formal document that attests to Estradiol Acetate's compliance with Estradiol Acetate specifications and serves as a tool for batch-level quality control.
Estradiol Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Estradiol Acetate 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 Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Estradiol Acetate EP), Estradiol Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Estradiol Acetate USP).
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