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Find Tamoxifen Citrate manufacturers, exporters & distributors on PharmaCompass

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  • TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;ORAL - EQ 20MG BASE/10ML

Looking for 54965-24-1 / Tamoxifen Citrate API manufacturers, exporters & distributors?

Tamoxifen Citrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Tamoxifen Citrate 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 Tamoxifen Citrate manufacturer or Tamoxifen Citrate supplier for your needs.

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

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

API | Excipient name

Tamoxifen Citrate

Synonyms

54965-24-1, Zitazonium, Istubal, Kessar, Zemide, Tamoxifen (citrate)

Cas Number

54965-24-1

Unique Ingredient Identifier (UNII)

7FRV7310N6

About Tamoxifen Citrate

One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.

Tamoxifen Manufacturers

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

Tamoxifen Suppliers

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

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

Tamoxifen USDMF

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

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

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

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

Tamoxifen KDMF

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

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

After submitting a Tamoxifen 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 Tamoxifen API can apply through the Korea Drug Master File (KDMF).

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

Tamoxifen CEP

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

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

Tamoxifen 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 Tamoxifen as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tamoxifen GMP

Tamoxifen 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 Tamoxifen 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 Tamoxifen GMP manufacturer or Tamoxifen GMP API supplier for your needs.

Tamoxifen CoA

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

Tamoxifen CoA mostly includes findings from lab analyses of a specific batch. For each Tamoxifen 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.

Tamoxifen may be tested according to a variety of international standards, such as European Pharmacopoeia (Tamoxifen EP), Tamoxifen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tamoxifen 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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