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API SUPPLIERS
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
KDMF
ASMF 
Suanfarma, at the Core of a Better Life.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
JDMF
KDMF
ASMF
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CEP/COS
CA, ASMF
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
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USDMF
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19765
Submission : 2006-09-12
Status :
Type : II
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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
Certificate Number : R1-CEP 2013-207 - Rev 00
Status : Valid
Issue Date : 2019-08-30
Type : Chemical
Substance Number : 2182
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : R1-CEP 2011-170 - Rev 01
Status : Valid
Issue Date : 2020-02-07
Type : Chemical
Substance Number : 2182
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
Certificate Number : CEP 2018-026 - Rev 01
Status : Valid
Issue Date : 2024-04-15
Type : Chemical
Substance Number : 2182
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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2011-03-31
Registration Number : 20110331-13-B-310-07
Manufacturer Name : ZACH SYSTEM
Manufacturer Address : ZI La Corix Cadeau, 49240 Avrille, France
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-13-B-55-02
Manufacturer Name : ZACH SYSTEM
Manufacturer Address : ZI La Corix Cadeau, 49240 Avrille, France
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-08-03
Registration Number : 20220803-13-B-463-14
Manufacturer Name : Moehs Cantabra, SL
Manufacturer Address : Poligono Industrial Requejada, Polanco 39313, Cantabria, Spain
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API Imports and Exports
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A Maleate, Trimebutine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maleate, Trimebutine, including repackagers and relabelers. The FDA regulates Maleate, Trimebutine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maleate, Trimebutine 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 Maleate, Trimebutine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maleate, Trimebutine supplier is an individual or a company that provides Maleate, Trimebutine active pharmaceutical ingredient (API) or Maleate, Trimebutine finished formulations upon request. The Maleate, Trimebutine suppliers may include Maleate, Trimebutine API manufacturers, exporters, distributors and traders.
click here to find a list of Maleate, Trimebutine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Maleate, Trimebutine DMF (Drug Master File) is a document detailing the whole manufacturing process of Maleate, Trimebutine active pharmaceutical ingredient (API) in detail. Different forms of Maleate, Trimebutine DMFs exist exist since differing nations have different regulations, such as Maleate, Trimebutine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maleate, Trimebutine DMF submitted to regulatory agencies in the US is known as a USDMF. Maleate, Trimebutine USDMF includes data on Maleate, Trimebutine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maleate, Trimebutine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Maleate, Trimebutine 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 Maleate, Trimebutine Drug Master File in Japan (Maleate, Trimebutine JDMF) empowers Maleate, Trimebutine 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 Maleate, Trimebutine JDMF during the approval evaluation for pharmaceutical products. At the time of Maleate, Trimebutine 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 Maleate, Trimebutine 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 Maleate, Trimebutine Drug Master File in Korea (Maleate, Trimebutine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Maleate, Trimebutine. The MFDS reviews the Maleate, Trimebutine KDMF as part of the drug registration process and uses the information provided in the Maleate, Trimebutine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Maleate, Trimebutine 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 Maleate, Trimebutine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Maleate, Trimebutine suppliers with KDMF on PharmaCompass.
A Maleate, Trimebutine CEP of the European Pharmacopoeia monograph is often referred to as a Maleate, Trimebutine Certificate of Suitability (COS). The purpose of a Maleate, Trimebutine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Maleate, Trimebutine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Maleate, Trimebutine to their clients by showing that a Maleate, Trimebutine CEP has been issued for it. The manufacturer submits a Maleate, Trimebutine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Maleate, Trimebutine CEP holder for the record. Additionally, the data presented in the Maleate, Trimebutine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Maleate, Trimebutine DMF.
A Maleate, Trimebutine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Maleate, Trimebutine 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 Maleate, Trimebutine suppliers with CEP (COS) 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 Maleate, Trimebutine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Maleate, Trimebutine 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 Maleate, Trimebutine 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 Maleate, Trimebutine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Maleate, Trimebutine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Maleate, Trimebutine suppliers with NDC on PharmaCompass.
Maleate, Trimebutine 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 Maleate, Trimebutine 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 Maleate, Trimebutine GMP manufacturer or Maleate, Trimebutine GMP API supplier for your needs.
A Maleate, Trimebutine CoA (Certificate of Analysis) is a formal document that attests to Maleate, Trimebutine's compliance with Maleate, Trimebutine specifications and serves as a tool for batch-level quality control.
Maleate, Trimebutine CoA mostly includes findings from lab analyses of a specific batch. For each Maleate, Trimebutine 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.
Maleate, Trimebutine may be tested according to a variety of international standards, such as European Pharmacopoeia (Maleate, Trimebutine EP), Maleate, Trimebutine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Maleate, Trimebutine USP).
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