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Looking for 313-06-4 / Estradiol Cypionate API manufacturers, exporters & distributors?

Estradiol Cypionate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Estradiol Cypionate 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 Cypionate manufacturer or Estradiol Cypionate supplier for your needs.

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

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

API | Excipient name

Estradiol Cypionate

Synonyms

313-06-4, Depofemin, Depoestradiol, Depo-estradiol, Depoestra, Estradep

Cas Number

313-06-4

Unique Ingredient Identifier (UNII)

7E1DV054LO

About Estradiol Cypionate

Estradiol Cypionate is the cypionate salt form of estradiol, the most potent, naturally produced estrogen. Estradiol cypionate diffuses through the cell membrane and binds to and subsequently activates the nuclear estrogen receptor found in the reproductive tract, breast, pituitary, hypothalamus, liver, and bone. The activated complex binds to the estrogen response element on the DNA and activates the transcription of genes involved in the functioning of the female reproductive system and secondary sex characteristics.

Estradiol 17.beta.-cypionate Manufacturers

A Estradiol 17.beta.-cypionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol 17.beta.-cypionate, including repackagers and relabelers. The FDA regulates Estradiol 17.beta.-cypionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol 17.beta.-cypionate 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 17.beta.-cypionate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Estradiol 17.beta.-cypionate Suppliers

A Estradiol 17.beta.-cypionate supplier is an individual or a company that provides Estradiol 17.beta.-cypionate active pharmaceutical ingredient (API) or Estradiol 17.beta.-cypionate finished formulations upon request. The Estradiol 17.beta.-cypionate suppliers may include Estradiol 17.beta.-cypionate API manufacturers, exporters, distributors and traders.

click here to find a list of Estradiol 17.beta.-cypionate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Estradiol 17.beta.-cypionate USDMF

A Estradiol 17.beta.-cypionate DMF (Drug Master File) is a document detailing the whole manufacturing process of Estradiol 17.beta.-cypionate active pharmaceutical ingredient (API) in detail. Different forms of Estradiol 17.beta.-cypionate DMFs exist exist since differing nations have different regulations, such as Estradiol 17.beta.-cypionate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Estradiol 17.beta.-cypionate DMF submitted to regulatory agencies in the US is known as a USDMF. Estradiol 17.beta.-cypionate USDMF includes data on Estradiol 17.beta.-cypionate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estradiol 17.beta.-cypionate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Estradiol 17.beta.-cypionate suppliers with USDMF on PharmaCompass.

Estradiol 17.beta.-cypionate CEP

A Estradiol 17.beta.-cypionate CEP of the European Pharmacopoeia monograph is often referred to as a Estradiol 17.beta.-cypionate Certificate of Suitability (COS). The purpose of a Estradiol 17.beta.-cypionate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Estradiol 17.beta.-cypionate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Estradiol 17.beta.-cypionate to their clients by showing that a Estradiol 17.beta.-cypionate CEP has been issued for it. The manufacturer submits a Estradiol 17.beta.-cypionate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Estradiol 17.beta.-cypionate CEP holder for the record. Additionally, the data presented in the Estradiol 17.beta.-cypionate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Estradiol 17.beta.-cypionate DMF.

A Estradiol 17.beta.-cypionate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Estradiol 17.beta.-cypionate 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 17.beta.-cypionate suppliers with CEP (COS) on PharmaCompass.

Estradiol 17.beta.-cypionate 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 17.beta.-cypionate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Estradiol 17.beta.-cypionate 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 17.beta.-cypionate 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 17.beta.-cypionate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Estradiol 17.beta.-cypionate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Estradiol 17.beta.-cypionate suppliers with NDC on PharmaCompass.

Estradiol 17.beta.-cypionate GMP

Estradiol 17.beta.-cypionate 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 17.beta.-cypionate 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 17.beta.-cypionate GMP manufacturer or Estradiol 17.beta.-cypionate GMP API supplier for your needs.

Estradiol 17.beta.-cypionate CoA

A Estradiol 17.beta.-cypionate CoA (Certificate of Analysis) is a formal document that attests to Estradiol 17.beta.-cypionate's compliance with Estradiol 17.beta.-cypionate specifications and serves as a tool for batch-level quality control.

Estradiol 17.beta.-cypionate CoA mostly includes findings from lab analyses of a specific batch. For each Estradiol 17.beta.-cypionate 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 17.beta.-cypionate may be tested according to a variety of international standards, such as European Pharmacopoeia (Estradiol 17.beta.-cypionate EP), Estradiol 17.beta.-cypionate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Estradiol 17.beta.-cypionate 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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