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ABOUT THIS PAGE
A Nicergoline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nicergoline, including repackagers and relabelers. The FDA regulates Nicergoline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nicergoline 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 Nicergoline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nicergoline supplier is an individual or a company that provides Nicergoline active pharmaceutical ingredient (API) or Nicergoline finished formulations upon request. The Nicergoline suppliers may include Nicergoline API manufacturers, exporters, distributors and traders.
click here to find a list of Nicergoline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nicergoline DMF (Drug Master File) is a document detailing the whole manufacturing process of Nicergoline active pharmaceutical ingredient (API) in detail. Different forms of Nicergoline DMFs exist exist since differing nations have different regulations, such as Nicergoline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nicergoline DMF submitted to regulatory agencies in the US is known as a USDMF. Nicergoline USDMF includes data on Nicergoline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nicergoline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nicergoline 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 Nicergoline Drug Master File in Japan (Nicergoline JDMF) empowers Nicergoline 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 Nicergoline JDMF during the approval evaluation for pharmaceutical products. At the time of Nicergoline 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 Nicergoline 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 Nicergoline Drug Master File in Korea (Nicergoline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nicergoline. The MFDS reviews the Nicergoline KDMF as part of the drug registration process and uses the information provided in the Nicergoline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nicergoline 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 Nicergoline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nicergoline suppliers with KDMF on PharmaCompass.
A Nicergoline CEP of the European Pharmacopoeia monograph is often referred to as a Nicergoline Certificate of Suitability (COS). The purpose of a Nicergoline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nicergoline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nicergoline to their clients by showing that a Nicergoline CEP has been issued for it. The manufacturer submits a Nicergoline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nicergoline CEP holder for the record. Additionally, the data presented in the Nicergoline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nicergoline DMF.
A Nicergoline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nicergoline 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 Nicergoline suppliers with CEP (COS) on PharmaCompass.
Nicergoline 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 Nicergoline 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 Nicergoline GMP manufacturer or Nicergoline GMP API supplier for your needs.
A Nicergoline CoA (Certificate of Analysis) is a formal document that attests to Nicergoline's compliance with Nicergoline specifications and serves as a tool for batch-level quality control.
Nicergoline CoA mostly includes findings from lab analyses of a specific batch. For each Nicergoline 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.
Nicergoline may be tested according to a variety of international standards, such as European Pharmacopoeia (Nicergoline EP), Nicergoline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nicergoline USP).
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