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API SUPPLIERS
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10948
Submission : 1994-06-20
Status :
Type : II
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R1-CEP 2015-302 - Rev 00
Status : Valid
Issue Date : 2022-01-31
Type : Chemical
Substance Number : 1488
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-02-02
Registration Number : 20230202-210-J-1440
Manufacturer Name : EUROAPI Hungary Ltd.
Manufacturer Address : To utca 1-5., Budapest, 1045, Hungary
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Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - 0.005MG/VIAL
USFDA APPLICATION NUMBER - 20379
DOSAGE - INJECTABLE;INJECTION - 0.01MG/VIAL
USFDA APPLICATION NUMBER - 20379
DOSAGE - INJECTABLE;INJECTION - 0.02MG/VIAL
USFDA APPLICATION NUMBER - 20379
DOSAGE - INJECTABLE;INJECTION - 0.04MG/VIAL
USFDA APPLICATION NUMBER - 20379
Related Excipient Companies
Nanjing Well Pharmaceutical
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REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Alprostadil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alprostadil, including repackagers and relabelers. The FDA regulates Alprostadil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alprostadil 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alprostadil supplier is an individual or a company that provides Alprostadil active pharmaceutical ingredient (API) or Alprostadil finished formulations upon request. The Alprostadil suppliers may include Alprostadil API manufacturers, exporters, distributors and traders.
click here to find a list of Alprostadil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alprostadil DMF (Drug Master File) is a document detailing the whole manufacturing process of Alprostadil active pharmaceutical ingredient (API) in detail. Different forms of Alprostadil DMFs exist exist since differing nations have different regulations, such as Alprostadil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alprostadil DMF submitted to regulatory agencies in the US is known as a USDMF. Alprostadil USDMF includes data on Alprostadil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alprostadil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alprostadil 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 Drug Master File in Japan (Alprostadil JDMF) empowers Alprostadil 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Alprostadil 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 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 Drug Master File in Korea (Alprostadil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alprostadil. The MFDS reviews the Alprostadil KDMF as part of the drug registration process and uses the information provided in the Alprostadil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alprostadil 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alprostadil suppliers with KDMF on PharmaCompass.
A Alprostadil CEP of the European Pharmacopoeia monograph is often referred to as a Alprostadil Certificate of Suitability (COS). The purpose of a Alprostadil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alprostadil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alprostadil to their clients by showing that a Alprostadil CEP has been issued for it. The manufacturer submits a Alprostadil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alprostadil CEP holder for the record. Additionally, the data presented in the Alprostadil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alprostadil DMF.
A Alprostadil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alprostadil 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 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alprostadil 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alprostadil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alprostadil suppliers with NDC on PharmaCompass.
Alprostadil 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 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 GMP manufacturer or Alprostadil GMP API supplier for your needs.
A Alprostadil CoA (Certificate of Analysis) is a formal document that attests to Alprostadil's compliance with Alprostadil specifications and serves as a tool for batch-level quality control.
Alprostadil CoA mostly includes findings from lab analyses of a specific batch. For each Alprostadil 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Alprostadil EP), Alprostadil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alprostadil USP).
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