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PharmaCompass offers a list of Conjugated Estrogens 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 Conjugated Estrogens manufacturer or Conjugated Estrogens supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Conjugated Estrogens manufacturer or Conjugated Estrogens supplier.
PharmaCompass also assists you with knowing the Conjugated Estrogens API Price utilized in the formulation of products. Conjugated Estrogens API Price is not always fixed or binding as the Conjugated Estrogens Price is obtained through a variety of data sources. The Conjugated Estrogens Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Premarin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Premarin, including repackagers and relabelers. The FDA regulates Premarin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Premarin 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 Premarin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Premarin supplier is an individual or a company that provides Premarin active pharmaceutical ingredient (API) or Premarin finished formulations upon request. The Premarin suppliers may include Premarin API manufacturers, exporters, distributors and traders.
click here to find a list of Premarin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Premarin DMF (Drug Master File) is a document detailing the whole manufacturing process of Premarin active pharmaceutical ingredient (API) in detail. Different forms of Premarin DMFs exist exist since differing nations have different regulations, such as Premarin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Premarin DMF submitted to regulatory agencies in the US is known as a USDMF. Premarin USDMF includes data on Premarin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Premarin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Premarin suppliers with USDMF 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 Premarin Drug Master File in Korea (Premarin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Premarin. The MFDS reviews the Premarin KDMF as part of the drug registration process and uses the information provided in the Premarin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Premarin 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 Premarin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Premarin suppliers with KDMF on PharmaCompass.
A Premarin CEP of the European Pharmacopoeia monograph is often referred to as a Premarin Certificate of Suitability (COS). The purpose of a Premarin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Premarin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Premarin to their clients by showing that a Premarin CEP has been issued for it. The manufacturer submits a Premarin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Premarin CEP holder for the record. Additionally, the data presented in the Premarin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Premarin DMF.
A Premarin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Premarin 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 Premarin suppliers with CEP (COS) on PharmaCompass.
A Premarin written confirmation (Premarin WC) is an official document issued by a regulatory agency to a Premarin manufacturer, verifying that the manufacturing facility of a Premarin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Premarin APIs or Premarin finished pharmaceutical products to another nation, regulatory agencies frequently require a Premarin WC (written confirmation) as part of the regulatory process.
click here to find a list of Premarin 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 Premarin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Premarin 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 Premarin 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 Premarin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Premarin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Premarin suppliers with NDC on PharmaCompass.
Premarin 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 Premarin 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 Premarin GMP manufacturer or Premarin GMP API supplier for your needs.
A Premarin CoA (Certificate of Analysis) is a formal document that attests to Premarin's compliance with Premarin specifications and serves as a tool for batch-level quality control.
Premarin CoA mostly includes findings from lab analyses of a specific batch. For each Premarin 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.
Premarin may be tested according to a variety of international standards, such as European Pharmacopoeia (Premarin EP), Premarin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Premarin USP).