Synopsis
0
EU WC
0
NDC API
0
VMF
0
FDA Orange Book
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
26
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 Sermion manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sermion, including repackagers and relabelers. The FDA regulates Sermion manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sermion 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 Sermion manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sermion supplier is an individual or a company that provides Sermion active pharmaceutical ingredient (API) or Sermion finished formulations upon request. The Sermion suppliers may include Sermion API manufacturers, exporters, distributors and traders.
click here to find a list of Sermion suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sermion DMF (Drug Master File) is a document detailing the whole manufacturing process of Sermion active pharmaceutical ingredient (API) in detail. Different forms of Sermion DMFs exist exist since differing nations have different regulations, such as Sermion USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sermion DMF submitted to regulatory agencies in the US is known as a USDMF. Sermion USDMF includes data on Sermion's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sermion USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sermion 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 Sermion Drug Master File in Japan (Sermion JDMF) empowers Sermion 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 Sermion JDMF during the approval evaluation for pharmaceutical products. At the time of Sermion 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 Sermion 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 Sermion Drug Master File in Korea (Sermion KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sermion. The MFDS reviews the Sermion KDMF as part of the drug registration process and uses the information provided in the Sermion KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sermion 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 Sermion API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sermion suppliers with KDMF on PharmaCompass.
A Sermion CEP of the European Pharmacopoeia monograph is often referred to as a Sermion Certificate of Suitability (COS). The purpose of a Sermion CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sermion EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sermion to their clients by showing that a Sermion CEP has been issued for it. The manufacturer submits a Sermion CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sermion CEP holder for the record. Additionally, the data presented in the Sermion CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sermion DMF.
A Sermion CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sermion 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 Sermion suppliers with CEP (COS) on PharmaCompass.
Sermion 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 Sermion 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 Sermion GMP manufacturer or Sermion GMP API supplier for your needs.
A Sermion CoA (Certificate of Analysis) is a formal document that attests to Sermion's compliance with Sermion specifications and serves as a tool for batch-level quality control.
Sermion CoA mostly includes findings from lab analyses of a specific batch. For each Sermion 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.
Sermion may be tested according to a variety of international standards, such as European Pharmacopoeia (Sermion EP), Sermion JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sermion USP).
