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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
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...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
Aspen API. More than just an API™
About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - 10MG/ML
USFDA APPLICATION NUMBER - 9402
DOSAGE - INJECTABLE;INJECTION - 20MG/ML
USFDA APPLICATION NUMBER - 9402
DOSAGE - INJECTABLE;INJECTION - 40MG/ML
USFDA APPLICATION NUMBER - 9402
Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
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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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Parenteral
Solubilizers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ANALYTICAL
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PharmaCompass offers a list of Estradiol Valerate 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 Valerate manufacturer or Estradiol Valerate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Estradiol Valerate manufacturer or Estradiol Valerate supplier.
PharmaCompass also assists you with knowing the Estradiol Valerate API Price utilized in the formulation of products. Estradiol Valerate API Price is not always fixed or binding as the Estradiol Valerate Price is obtained through a variety of data sources. The Estradiol Valerate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gynokadin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gynokadin, including repackagers and relabelers. The FDA regulates Gynokadin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gynokadin 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 Gynokadin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gynokadin supplier is an individual or a company that provides Gynokadin active pharmaceutical ingredient (API) or Gynokadin finished formulations upon request. The Gynokadin suppliers may include Gynokadin API manufacturers, exporters, distributors and traders.
click here to find a list of Gynokadin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gynokadin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gynokadin active pharmaceutical ingredient (API) in detail. Different forms of Gynokadin DMFs exist exist since differing nations have different regulations, such as Gynokadin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gynokadin DMF submitted to regulatory agencies in the US is known as a USDMF. Gynokadin USDMF includes data on Gynokadin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gynokadin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gynokadin 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 Gynokadin Drug Master File in Japan (Gynokadin JDMF) empowers Gynokadin 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 Gynokadin JDMF during the approval evaluation for pharmaceutical products. At the time of Gynokadin 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 Gynokadin 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 Gynokadin Drug Master File in Korea (Gynokadin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gynokadin. The MFDS reviews the Gynokadin KDMF as part of the drug registration process and uses the information provided in the Gynokadin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gynokadin 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 Gynokadin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gynokadin suppliers with KDMF on PharmaCompass.
A Gynokadin CEP of the European Pharmacopoeia monograph is often referred to as a Gynokadin Certificate of Suitability (COS). The purpose of a Gynokadin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gynokadin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gynokadin to their clients by showing that a Gynokadin CEP has been issued for it. The manufacturer submits a Gynokadin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gynokadin CEP holder for the record. Additionally, the data presented in the Gynokadin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gynokadin DMF.
A Gynokadin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gynokadin 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 Gynokadin suppliers with CEP (COS) on PharmaCompass.
A Gynokadin written confirmation (Gynokadin WC) is an official document issued by a regulatory agency to a Gynokadin manufacturer, verifying that the manufacturing facility of a Gynokadin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gynokadin APIs or Gynokadin finished pharmaceutical products to another nation, regulatory agencies frequently require a Gynokadin WC (written confirmation) as part of the regulatory process.
click here to find a list of Gynokadin 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 Gynokadin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gynokadin 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 Gynokadin 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 Gynokadin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gynokadin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gynokadin suppliers with NDC on PharmaCompass.
Gynokadin 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 Gynokadin 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 Gynokadin GMP manufacturer or Gynokadin GMP API supplier for your needs.
A Gynokadin CoA (Certificate of Analysis) is a formal document that attests to Gynokadin's compliance with Gynokadin specifications and serves as a tool for batch-level quality control.
Gynokadin CoA mostly includes findings from lab analyses of a specific batch. For each Gynokadin 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.
Gynokadin may be tested according to a variety of international standards, such as European Pharmacopoeia (Gynokadin EP), Gynokadin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gynokadin USP).
