Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
NDC
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Axplora- The partner of choice for complex APIs.
CEP/COS
NDC
Minakem is manufacturing small molecules APIs including corticosteroids
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
CEP/COS
CA, ASMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
CA, ASMF
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USDMF
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-29
Pay. Date : 2020-07-17
DMF Number : 32949
Submission : 2018-07-27
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22174
Submission : 2008-11-12
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-27
Pay. Date : 2013-02-20
DMF Number : 26835
Submission : 2013-03-15
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Certificate Number : CEP 2024-002 - Rev 00
Status : Valid
Issue Date : 2024-10-15
Type : Chemical
Substance Number : 2443
Axplora- The partner of choice for complex APIs.
Certificate Number : R1-CEP 2016-169 - Rev 00
Status : Valid
Issue Date : 2023-02-22
Type : Chemical
Substance Number : 2443
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : R1-CEP 2013-255 - Rev 02
Status : Valid
Issue Date : 2023-08-21
Type : Chemical
Substance Number : 2443
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Axplora- The partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
Minakem is manufacturing small molecules APIs including corticosteroids
About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
About the Company : Capital Farma offers a comprehensive range of pharmaceutical solutions. Our API offering includes active ingredients sourced exclusively from top European manufacturers, ensuring t...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Drugs in Development
Lead Product(s) : Palbociclib,Fulvestrant
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Dr. Reddy’s Launches In-House Palbociclib (PRIMCYV®) To Widen Access to High-Quality Breast Can...
Details : PRIMCYV® is a targeted therapy containing the active constituent palbociclib, a first-in-class CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of adult patients with HR+, HER2- metastatic breast cancer...
Product Name : Primcyv
Product Type : Small molecule
Upfront Cash : Not Applicable
January 13, 2023
Lead Product(s) : Fulvestrant
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Dr. Reddy’s Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe is available in a carton containing two 5 mL single-dose prefilled syringes.
Product Name : Fulvestrant-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
September 07, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;INTRAMUSCULAR - 125MG/2.5ML...DOSAGE - SOLUTION;INTRAMUSCULAR - 125MG/2.5ML (50MG/ML)
USFDA APPLICATION NUMBER - 21344
DOSAGE - SOLUTION;INTRAMUSCULAR - 250MG/5ML (...DOSAGE - SOLUTION;INTRAMUSCULAR - 250MG/5ML (50MG/ML)
USFDA APPLICATION NUMBER - 21344
Related Excipient Companies
Nanjing Well Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]TopChem Pharmaceuticals
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Topical
Solubilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Fulvestrant 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 Fulvestrant manufacturer or Fulvestrant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fulvestrant manufacturer or Fulvestrant supplier.
PharmaCompass also assists you with knowing the Fulvestrant API Price utilized in the formulation of products. Fulvestrant API Price is not always fixed or binding as the Fulvestrant Price is obtained through a variety of data sources. The Fulvestrant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fulvestrant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fulvestrant, including repackagers and relabelers. The FDA regulates Fulvestrant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fulvestrant 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 Fulvestrant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fulvestrant supplier is an individual or a company that provides Fulvestrant active pharmaceutical ingredient (API) or Fulvestrant finished formulations upon request. The Fulvestrant suppliers may include Fulvestrant API manufacturers, exporters, distributors and traders.
click here to find a list of Fulvestrant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fulvestrant DMF (Drug Master File) is a document detailing the whole manufacturing process of Fulvestrant active pharmaceutical ingredient (API) in detail. Different forms of Fulvestrant DMFs exist exist since differing nations have different regulations, such as Fulvestrant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fulvestrant DMF submitted to regulatory agencies in the US is known as a USDMF. Fulvestrant USDMF includes data on Fulvestrant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fulvestrant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fulvestrant suppliers with USDMF on PharmaCompass.
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 Fulvestrant Drug Master File in Japan (Fulvestrant JDMF) empowers Fulvestrant 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 Fulvestrant JDMF during the approval evaluation for pharmaceutical products. At the time of Fulvestrant 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 Fulvestrant suppliers with JDMF on PharmaCompass.
A Fulvestrant CEP of the European Pharmacopoeia monograph is often referred to as a Fulvestrant Certificate of Suitability (COS). The purpose of a Fulvestrant CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fulvestrant EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fulvestrant to their clients by showing that a Fulvestrant CEP has been issued for it. The manufacturer submits a Fulvestrant CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fulvestrant CEP holder for the record. Additionally, the data presented in the Fulvestrant CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fulvestrant DMF.
A Fulvestrant CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fulvestrant 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 Fulvestrant suppliers with CEP (COS) on PharmaCompass.
A Fulvestrant written confirmation (Fulvestrant WC) is an official document issued by a regulatory agency to a Fulvestrant manufacturer, verifying that the manufacturing facility of a Fulvestrant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fulvestrant APIs or Fulvestrant finished pharmaceutical products to another nation, regulatory agencies frequently require a Fulvestrant WC (written confirmation) as part of the regulatory process.
click here to find a list of Fulvestrant suppliers with Written Confirmation (WC) 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 Fulvestrant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fulvestrant 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 Fulvestrant 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 Fulvestrant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fulvestrant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fulvestrant suppliers with NDC on PharmaCompass.
Fulvestrant 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 Fulvestrant 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 Fulvestrant GMP manufacturer or Fulvestrant GMP API supplier for your needs.
A Fulvestrant CoA (Certificate of Analysis) is a formal document that attests to Fulvestrant's compliance with Fulvestrant specifications and serves as a tool for batch-level quality control.
Fulvestrant CoA mostly includes findings from lab analyses of a specific batch. For each Fulvestrant 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.
Fulvestrant may be tested according to a variety of international standards, such as European Pharmacopoeia (Fulvestrant EP), Fulvestrant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fulvestrant USP).
