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