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PharmaCompass offers a list of Alprostadil 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 Alprostadil manufacturer or Alprostadil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alprostadil manufacturer or Alprostadil supplier.
PharmaCompass also assists you with knowing the Alprostadil API Price utilized in the formulation of products. Alprostadil API Price is not always fixed or binding as the Alprostadil Price is obtained through a variety of data sources. The Alprostadil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alprostadil Prostoglandin E1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alprostadil Prostoglandin E1, including repackagers and relabelers. The FDA regulates Alprostadil Prostoglandin E1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alprostadil Prostoglandin E1 supplier is an individual or a company that provides Alprostadil Prostoglandin E1 active pharmaceutical ingredient (API) or Alprostadil Prostoglandin E1 finished formulations upon request. The Alprostadil Prostoglandin E1 suppliers may include Alprostadil Prostoglandin E1 API manufacturers, exporters, distributors and traders.
click here to find a list of Alprostadil Prostoglandin E1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alprostadil Prostoglandin E1 DMF (Drug Master File) is a document detailing the whole manufacturing process of Alprostadil Prostoglandin E1 active pharmaceutical ingredient (API) in detail. Different forms of Alprostadil Prostoglandin E1 DMFs exist exist since differing nations have different regulations, such as Alprostadil Prostoglandin E1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alprostadil Prostoglandin E1 DMF submitted to regulatory agencies in the US is known as a USDMF. Alprostadil Prostoglandin E1 USDMF includes data on Alprostadil Prostoglandin E1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alprostadil Prostoglandin E1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 Drug Master File in Japan (Alprostadil Prostoglandin E1 JDMF) empowers Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 JDMF during the approval evaluation for pharmaceutical products. At the time of Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 Drug Master File in Korea (Alprostadil Prostoglandin E1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alprostadil Prostoglandin E1. The MFDS reviews the Alprostadil Prostoglandin E1 KDMF as part of the drug registration process and uses the information provided in the Alprostadil Prostoglandin E1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alprostadil Prostoglandin E1 suppliers with KDMF on PharmaCompass.
A Alprostadil Prostoglandin E1 CEP of the European Pharmacopoeia monograph is often referred to as a Alprostadil Prostoglandin E1 Certificate of Suitability (COS). The purpose of a Alprostadil Prostoglandin E1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alprostadil Prostoglandin E1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alprostadil Prostoglandin E1 to their clients by showing that a Alprostadil Prostoglandin E1 CEP has been issued for it. The manufacturer submits a Alprostadil Prostoglandin E1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alprostadil Prostoglandin E1 CEP holder for the record. Additionally, the data presented in the Alprostadil Prostoglandin E1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alprostadil Prostoglandin E1 DMF.
A Alprostadil Prostoglandin E1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 suppliers with CEP (COS) 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 Alprostadil Prostoglandin E1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alprostadil Prostoglandin E1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alprostadil Prostoglandin E1 suppliers with NDC on PharmaCompass.
Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 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 Alprostadil Prostoglandin E1 GMP manufacturer or Alprostadil Prostoglandin E1 GMP API supplier for your needs.
A Alprostadil Prostoglandin E1 CoA (Certificate of Analysis) is a formal document that attests to Alprostadil Prostoglandin E1's compliance with Alprostadil Prostoglandin E1 specifications and serves as a tool for batch-level quality control.
Alprostadil Prostoglandin E1 CoA mostly includes findings from lab analyses of a specific batch. For each Alprostadil Prostoglandin E1 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.
Alprostadil Prostoglandin E1 may be tested according to a variety of international standards, such as European Pharmacopoeia (Alprostadil Prostoglandin E1 EP), Alprostadil Prostoglandin E1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alprostadil Prostoglandin E1 USP).
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