Synopsis
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EU WC
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NDC API
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VMF
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FDA Orange Book
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Lifecare Labs has been developing innovative products in specialist areas of medicine.
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
JDMF
ASMF 
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
ASMF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 2003-198 - Rev 05
Status : Valid
Issue Date : 2025-01-13
Type : Chemical
Substance Number : 1998
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registration Number : 220MF10070
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2008-02-25
Latest Date of Registration : 2008-02-25
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registration Number : 306MF10154
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2024-12-04
Latest Date of Registration : 2024-12-04
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Lifecare Labs has been developing innovative products in specialist areas of medicine.
About the Company : Lifecare Labs specializes in producing bulk drugs (APIs) and intermediates that adhere to the industry's stringent quality parameters. Its objective is to deliver excellence throug...
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
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Global Sales Information
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Nicergoline 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 Nicergoline manufacturer or Nicergoline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nicergoline manufacturer or Nicergoline supplier.
PharmaCompass also assists you with knowing the Nicergoline API Price utilized in the formulation of products. Nicergoline API Price is not always fixed or binding as the Nicergoline Price is obtained through a variety of data sources. The Nicergoline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A N0904 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N0904, including repackagers and relabelers. The FDA regulates N0904 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N0904 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 N0904 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A N0904 supplier is an individual or a company that provides N0904 active pharmaceutical ingredient (API) or N0904 finished formulations upon request. The N0904 suppliers may include N0904 API manufacturers, exporters, distributors and traders.
click here to find a list of N0904 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N0904 DMF (Drug Master File) is a document detailing the whole manufacturing process of N0904 active pharmaceutical ingredient (API) in detail. Different forms of N0904 DMFs exist exist since differing nations have different regulations, such as N0904 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N0904 DMF submitted to regulatory agencies in the US is known as a USDMF. N0904 USDMF includes data on N0904's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N0904 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N0904 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 N0904 Drug Master File in Japan (N0904 JDMF) empowers N0904 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 N0904 JDMF during the approval evaluation for pharmaceutical products. At the time of N0904 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 N0904 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 N0904 Drug Master File in Korea (N0904 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of N0904. The MFDS reviews the N0904 KDMF as part of the drug registration process and uses the information provided in the N0904 KDMF to evaluate the safety and efficacy of the drug.
After submitting a N0904 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 N0904 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of N0904 suppliers with KDMF on PharmaCompass.
A N0904 CEP of the European Pharmacopoeia monograph is often referred to as a N0904 Certificate of Suitability (COS). The purpose of a N0904 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of N0904 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of N0904 to their clients by showing that a N0904 CEP has been issued for it. The manufacturer submits a N0904 CEP (COS) as part of the market authorization procedure, and it takes on the role of a N0904 CEP holder for the record. Additionally, the data presented in the N0904 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the N0904 DMF.
A N0904 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. N0904 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 N0904 suppliers with CEP (COS) on PharmaCompass.
N0904 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 N0904 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 N0904 GMP manufacturer or N0904 GMP API supplier for your needs.
A N0904 CoA (Certificate of Analysis) is a formal document that attests to N0904's compliance with N0904 specifications and serves as a tool for batch-level quality control.
N0904 CoA mostly includes findings from lab analyses of a specific batch. For each N0904 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.
N0904 may be tested according to a variety of international standards, such as European Pharmacopoeia (N0904 EP), N0904 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (N0904 USP).
