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  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR
  • INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR
  • SYSTEM;TRANSDERMAL - 0.025MG/24HR
  • SYSTEM;TRANSDERMAL - 0.0375MG/24HR
  • SYSTEM;TRANSDERMAL - 0.05MG/24HR
  • SYSTEM;TRANSDERMAL - 0.075MG/24HR
  • SYSTEM;TRANSDERMAL - 0.1MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
  • TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 1MG;0.5MG
  • TABLET;VAGINAL - 10MCG
  • TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION)
  • TABLET;ORAL - 0.25MG;0.5MG
  • TABLET;ORAL - 0.5MG;1MG
  • GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION)
  • SPRAY;TRANSDERMAL - 1.53MG/SPRAY
  • GEL;TRANSDERMAL - 0.1%
  • CREAM;VAGINAL - 0.01%

Looking for 50-28-2 / Estradiol API manufacturers, exporters & distributors?

Estradiol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Estradiol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Estradiol manufacturer or Estradiol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Estradiol manufacturer or Estradiol supplier.

PharmaCompass also assists you with knowing the Estradiol API Price utilized in the formulation of products. Estradiol API Price is not always fixed or binding as the Estradiol Price is obtained through a variety of data sources. The Estradiol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Estradiol

Synonyms

Beta-estradiol, 17beta-estradiol, 50-28-2, Oestradiol, Dihydrofolliculin, Estrace

Cas Number

50-28-2

Unique Ingredient Identifier (UNII)

4TI98Z838E

About Estradiol

The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids.

Estradiol Hemihydrate Manufacturers

A Estradiol Hemihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Hemihydrate, including repackagers and relabelers. The FDA regulates Estradiol Hemihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Hemihydrate 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 Hemihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Estradiol Hemihydrate Suppliers

A Estradiol Hemihydrate supplier is an individual or a company that provides Estradiol Hemihydrate active pharmaceutical ingredient (API) or Estradiol Hemihydrate finished formulations upon request. The Estradiol Hemihydrate suppliers may include Estradiol Hemihydrate API manufacturers, exporters, distributors and traders.

click here to find a list of Estradiol Hemihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Estradiol Hemihydrate USDMF

A Estradiol Hemihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Estradiol Hemihydrate active pharmaceutical ingredient (API) in detail. Different forms of Estradiol Hemihydrate DMFs exist exist since differing nations have different regulations, such as Estradiol Hemihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Estradiol Hemihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Estradiol Hemihydrate USDMF includes data on Estradiol Hemihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estradiol Hemihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Estradiol Hemihydrate suppliers with USDMF on PharmaCompass.

Estradiol Hemihydrate JDMF

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 Estradiol Hemihydrate Drug Master File in Japan (Estradiol Hemihydrate JDMF) empowers Estradiol Hemihydrate 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 Estradiol Hemihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Estradiol Hemihydrate 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 Estradiol Hemihydrate suppliers with JDMF on PharmaCompass.

Estradiol Hemihydrate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Estradiol Hemihydrate Drug Master File in Korea (Estradiol Hemihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Estradiol Hemihydrate. The MFDS reviews the Estradiol Hemihydrate KDMF as part of the drug registration process and uses the information provided in the Estradiol Hemihydrate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Estradiol Hemihydrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Estradiol Hemihydrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Estradiol Hemihydrate suppliers with KDMF on PharmaCompass.

Estradiol Hemihydrate CEP

A Estradiol Hemihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Estradiol Hemihydrate Certificate of Suitability (COS). The purpose of a Estradiol Hemihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Estradiol Hemihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Estradiol Hemihydrate to their clients by showing that a Estradiol Hemihydrate CEP has been issued for it. The manufacturer submits a Estradiol Hemihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Estradiol Hemihydrate CEP holder for the record. Additionally, the data presented in the Estradiol Hemihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Estradiol Hemihydrate DMF.

A Estradiol Hemihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Estradiol Hemihydrate 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 Hemihydrate suppliers with CEP (COS) on PharmaCompass.

Estradiol Hemihydrate WC

A Estradiol Hemihydrate written confirmation (Estradiol Hemihydrate WC) is an official document issued by a regulatory agency to a Estradiol Hemihydrate manufacturer, verifying that the manufacturing facility of a Estradiol Hemihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Estradiol Hemihydrate APIs or Estradiol Hemihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Estradiol Hemihydrate WC (written confirmation) as part of the regulatory process.

click here to find a list of Estradiol Hemihydrate suppliers with Written Confirmation (WC) on PharmaCompass.

Estradiol Hemihydrate NDC

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 Hemihydrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Estradiol Hemihydrate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Hemihydrate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Estradiol Hemihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Estradiol Hemihydrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Estradiol Hemihydrate suppliers with NDC on PharmaCompass.

Estradiol Hemihydrate GMP

Estradiol Hemihydrate 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 Hemihydrate 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 Hemihydrate GMP manufacturer or Estradiol Hemihydrate GMP API supplier for your needs.

Estradiol Hemihydrate CoA

A Estradiol Hemihydrate CoA (Certificate of Analysis) is a formal document that attests to Estradiol Hemihydrate's compliance with Estradiol Hemihydrate specifications and serves as a tool for batch-level quality control.

Estradiol Hemihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Estradiol Hemihydrate 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 Hemihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Estradiol Hemihydrate EP), Estradiol Hemihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Estradiol Hemihydrate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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