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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Registrant Name : DKS Korea Co., Ltd.
Registration Date : 2003-04-18
Registration Number : 163-1-ND
Manufacturer Name : Evonik Degussa Canada Inc.
Manufacturer Address : 8045 Argyll Road, Edmonton, Alberta, T6C 4N9, Canada.
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ABOUT THIS PAGE
A Verteporfin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Verteporfin, including repackagers and relabelers. The FDA regulates Verteporfin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Verteporfin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Verteporfin supplier is an individual or a company that provides Verteporfin active pharmaceutical ingredient (API) or Verteporfin finished formulations upon request. The Verteporfin suppliers may include Verteporfin API manufacturers, exporters, distributors and traders.
click here to find a list of Verteporfin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Verteporfin DMF (Drug Master File) is a document detailing the whole manufacturing process of Verteporfin active pharmaceutical ingredient (API) in detail. Different forms of Verteporfin DMFs exist exist since differing nations have different regulations, such as Verteporfin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Verteporfin DMF submitted to regulatory agencies in the US is known as a USDMF. Verteporfin USDMF includes data on Verteporfin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Verteporfin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Verteporfin 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 Verteporfin Drug Master File in Korea (Verteporfin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Verteporfin. The MFDS reviews the Verteporfin KDMF as part of the drug registration process and uses the information provided in the Verteporfin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Verteporfin 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 Verteporfin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Verteporfin suppliers with KDMF on PharmaCompass.
Verteporfin 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 Verteporfin 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 Verteporfin GMP manufacturer or Verteporfin GMP API supplier for your needs.
A Verteporfin CoA (Certificate of Analysis) is a formal document that attests to Verteporfin's compliance with Verteporfin specifications and serves as a tool for batch-level quality control.
Verteporfin CoA mostly includes findings from lab analyses of a specific batch. For each Verteporfin 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.
Verteporfin may be tested according to a variety of international standards, such as European Pharmacopoeia (Verteporfin EP), Verteporfin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Verteporfin USP).
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