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API SUPPLIERS
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registration Number : 226MF10117
Registrant's Address : Cesar Martinell i Brunet 12A, Poligono Rubi Sur, Rubi (Barcelona), Spain
Initial Date of Registration : 2014-06-18
Latest Date of Registration : 2023-03-07
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Date of Issue : 2025-07-24
Valid Till : 2028-07-21
Written Confirmation Number : WC-0150N
Address of the Firm : API Unit-l, R.S. No. 50/1, Mukteswarapuram Village,\r\nJaggaiahpet Mandal, NTR D...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
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 : Sam-O 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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Trimebutine Maleate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Trimebutine Maleate manufacturer or Trimebutine Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trimebutine Maleate manufacturer or Trimebutine Maleate supplier.
A Modulon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Modulon, including repackagers and relabelers. The FDA regulates Modulon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Modulon 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 Modulon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Modulon supplier is an individual or a company that provides Modulon active pharmaceutical ingredient (API) or Modulon finished formulations upon request. The Modulon suppliers may include Modulon API manufacturers, exporters, distributors and traders.
click here to find a list of Modulon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Modulon DMF (Drug Master File) is a document detailing the whole manufacturing process of Modulon active pharmaceutical ingredient (API) in detail. Different forms of Modulon DMFs exist exist since differing nations have different regulations, such as Modulon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Modulon DMF submitted to regulatory agencies in the US is known as a USDMF. Modulon USDMF includes data on Modulon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Modulon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Modulon 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 Modulon Drug Master File in Japan (Modulon JDMF) empowers Modulon 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 Modulon JDMF during the approval evaluation for pharmaceutical products. At the time of Modulon 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 Modulon 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 Modulon Drug Master File in Korea (Modulon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Modulon. The MFDS reviews the Modulon KDMF as part of the drug registration process and uses the information provided in the Modulon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Modulon 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 Modulon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Modulon suppliers with KDMF on PharmaCompass.
A Modulon CEP of the European Pharmacopoeia monograph is often referred to as a Modulon Certificate of Suitability (COS). The purpose of a Modulon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Modulon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Modulon to their clients by showing that a Modulon CEP has been issued for it. The manufacturer submits a Modulon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Modulon CEP holder for the record. Additionally, the data presented in the Modulon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Modulon DMF.
A Modulon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Modulon 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 Modulon suppliers with CEP (COS) on PharmaCompass.
A Modulon written confirmation (Modulon WC) is an official document issued by a regulatory agency to a Modulon manufacturer, verifying that the manufacturing facility of a Modulon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Modulon APIs or Modulon finished pharmaceutical products to another nation, regulatory agencies frequently require a Modulon WC (written confirmation) as part of the regulatory process.
click here to find a list of Modulon suppliers with Written Confirmation (WC) on PharmaCompass.
Modulon 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 Modulon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Modulon GMP manufacturer or Modulon GMP API supplier for your needs.
A Modulon CoA (Certificate of Analysis) is a formal document that attests to Modulon's compliance with Modulon specifications and serves as a tool for batch-level quality control.
Modulon CoA mostly includes findings from lab analyses of a specific batch. For each Modulon 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.
Modulon may be tested according to a variety of international standards, such as European Pharmacopoeia (Modulon EP), Modulon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Modulon USP).
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