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USDMF
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : Tanabe Pharma Korea Co., Ltd.
Registration Date : 2014-10-28
Registration Number : Su2480-16-ND
Manufacturer Name : Minakem High Potent SA
Manufacturer Address : Rue Fonds Jean Paques 8, Mont-Saint-Guibert, 1435 Belgium
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Samung Industry Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom_x000D_
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND(2)
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Veranova: A CDMO that manages complexity with confidence.
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND(1)
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2016-08-18
Registration Number : Su181-3-ND
Manufacturer Name : Fine Chemicals Corporation (...
Manufacturer Address : 15 Hawkins Avenue, Epping 1, Cape Town, 7460, South Africa
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2019-02-26
Registration Number : Su181-3-ND(1)
Manufacturer Name : Fine Chemicals Corporation
Manufacturer Address : 15 Hawkins Avenue, Epping 1, Cape Town, 7460, South Africa
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ABOUT THIS PAGE
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PharmaCompass offers a list of Remifentanil API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Remifentanil manufacturer or Remifentanil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Remifentanil manufacturer or Remifentanil supplier.
A Ultiva manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ultiva, including repackagers and relabelers. The FDA regulates Ultiva manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ultiva 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 Ultiva manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ultiva supplier is an individual or a company that provides Ultiva active pharmaceutical ingredient (API) or Ultiva finished formulations upon request. The Ultiva suppliers may include Ultiva API manufacturers, exporters, distributors and traders.
click here to find a list of Ultiva suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ultiva DMF (Drug Master File) is a document detailing the whole manufacturing process of Ultiva active pharmaceutical ingredient (API) in detail. Different forms of Ultiva DMFs exist exist since differing nations have different regulations, such as Ultiva USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ultiva DMF submitted to regulatory agencies in the US is known as a USDMF. Ultiva USDMF includes data on Ultiva's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ultiva USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ultiva 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 Ultiva Drug Master File in Japan (Ultiva JDMF) empowers Ultiva 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 Ultiva JDMF during the approval evaluation for pharmaceutical products. At the time of Ultiva 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 Ultiva 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 Ultiva Drug Master File in Korea (Ultiva KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ultiva. The MFDS reviews the Ultiva KDMF as part of the drug registration process and uses the information provided in the Ultiva KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ultiva 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 Ultiva API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ultiva suppliers with KDMF on PharmaCompass.
A Ultiva CEP of the European Pharmacopoeia monograph is often referred to as a Ultiva Certificate of Suitability (COS). The purpose of a Ultiva CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ultiva EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ultiva to their clients by showing that a Ultiva CEP has been issued for it. The manufacturer submits a Ultiva CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ultiva CEP holder for the record. Additionally, the data presented in the Ultiva CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ultiva DMF.
A Ultiva CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ultiva 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 Ultiva suppliers with CEP (COS) on PharmaCompass.
A Ultiva written confirmation (Ultiva WC) is an official document issued by a regulatory agency to a Ultiva manufacturer, verifying that the manufacturing facility of a Ultiva active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ultiva APIs or Ultiva finished pharmaceutical products to another nation, regulatory agencies frequently require a Ultiva WC (written confirmation) as part of the regulatory process.
click here to find a list of Ultiva 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 Ultiva as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ultiva 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 Ultiva 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 Ultiva and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ultiva NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ultiva suppliers with NDC on PharmaCompass.
Ultiva 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 Ultiva GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ultiva GMP manufacturer or Ultiva GMP API supplier for your needs.
A Ultiva CoA (Certificate of Analysis) is a formal document that attests to Ultiva's compliance with Ultiva specifications and serves as a tool for batch-level quality control.
Ultiva CoA mostly includes findings from lab analyses of a specific batch. For each Ultiva 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.
Ultiva may be tested according to a variety of international standards, such as European Pharmacopoeia (Ultiva EP), Ultiva JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ultiva USP).
