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JDMF
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Canada
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
LEBSA- Your strategic API source for niche molecules.
ASMF 
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
With Virupaksha, you get a quality product with on-time delivery.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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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
LEBSA- Your strategic API source for niche molecules.
Certificate Number : R1-CEP 2003-099 - Rev 03
Status : Valid
Issue Date : 2019-09-02
Type : Chemical
Substance Number : 1490
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : CEP 2002-208 - Rev 10
Status : Valid
Issue Date : 2024-05-27
Type : Chemical
Substance Number : 1490
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R0-CEP 2019-265 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2020-03-26
Type : Chemical
Substance Number : 1490
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2022-09-22
Registration Number : 20220922-209-J-1388
Manufacturer Name : Sanofi Winthrop Industrie
Manufacturer Address : 45 Chemin De Météline, Sisteron, 04200, France
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
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PharmaCompass offers a list of Amisulpride 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 Amisulpride manufacturer or Amisulpride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amisulpride manufacturer or Amisulpride supplier.
PharmaCompass also assists you with knowing the Amisulpride API Price utilized in the formulation of products. Amisulpride API Price is not always fixed or binding as the Amisulpride Price is obtained through a variety of data sources. The Amisulpride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Deniban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deniban, including repackagers and relabelers. The FDA regulates Deniban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deniban 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 Deniban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Deniban supplier is an individual or a company that provides Deniban active pharmaceutical ingredient (API) or Deniban finished formulations upon request. The Deniban suppliers may include Deniban API manufacturers, exporters, distributors and traders.
click here to find a list of Deniban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Deniban DMF (Drug Master File) is a document detailing the whole manufacturing process of Deniban active pharmaceutical ingredient (API) in detail. Different forms of Deniban DMFs exist exist since differing nations have different regulations, such as Deniban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Deniban DMF submitted to regulatory agencies in the US is known as a USDMF. Deniban USDMF includes data on Deniban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deniban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Deniban 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 Deniban Drug Master File in Korea (Deniban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Deniban. The MFDS reviews the Deniban KDMF as part of the drug registration process and uses the information provided in the Deniban KDMF to evaluate the safety and efficacy of the drug.
After submitting a Deniban 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 Deniban API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Deniban suppliers with KDMF on PharmaCompass.
A Deniban CEP of the European Pharmacopoeia monograph is often referred to as a Deniban Certificate of Suitability (COS). The purpose of a Deniban CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Deniban EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Deniban to their clients by showing that a Deniban CEP has been issued for it. The manufacturer submits a Deniban CEP (COS) as part of the market authorization procedure, and it takes on the role of a Deniban CEP holder for the record. Additionally, the data presented in the Deniban CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Deniban DMF.
A Deniban CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Deniban 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 Deniban suppliers with CEP (COS) on PharmaCompass.
A Deniban written confirmation (Deniban WC) is an official document issued by a regulatory agency to a Deniban manufacturer, verifying that the manufacturing facility of a Deniban active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Deniban APIs or Deniban finished pharmaceutical products to another nation, regulatory agencies frequently require a Deniban WC (written confirmation) as part of the regulatory process.
click here to find a list of Deniban 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 Deniban as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Deniban 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 Deniban 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 Deniban and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deniban NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Deniban suppliers with NDC on PharmaCompass.
Deniban 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 Deniban 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 Deniban GMP manufacturer or Deniban GMP API supplier for your needs.
A Deniban CoA (Certificate of Analysis) is a formal document that attests to Deniban's compliance with Deniban specifications and serves as a tool for batch-level quality control.
Deniban CoA mostly includes findings from lab analyses of a specific batch. For each Deniban 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.
Deniban may be tested according to a variety of international standards, such as European Pharmacopoeia (Deniban EP), Deniban JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deniban USP).
