Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Palbociclib,Fulvestrant
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Miscellaneous
Upfront Cash : Inapplicable
January 13, 2023
Lead Product(s) : Fulvestrant,Palbociclib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Miscellaneous
Upfront Cash : Inapplicable
September 07, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Your reliable CDMO partner - agile, scalable, top-quality Small Molecule API & HPAPI solutions from concept to market
4,4,5,5,5-Pentafluoro-1-pentanol
CAS Number : 148043-73-6
End Use API : Fulvestrant
About The Company : AGC Pharma Chemicals Europe is a leading CDMO partner for Small Molecule APIs, HPAPIs, and intermediates. It provides comprehensive, agile, and innovative solut...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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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
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Parenteral
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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, 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.
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, and COA 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, and COA 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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Fulvestrant Drug Master File in Korea (Fulvestrant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fulvestrant. The MFDS reviews the Fulvestrant KDMF as part of the drug registration process and uses the information provided in the Fulvestrant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fulvestrant 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 Fulvestrant API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fulvestrant suppliers with KDMF 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, 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).
