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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
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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
About the Company : Zach System, a subsidiary of Zambon Company, specializes in providing active pharmaceutical ingredients (APIs), intermediates and custom synthesis services that align with customer...
Suanfarma, at the Core of a Better Life.
About the Company : Suanfarma is a B2B life sciences company dedicated to health and advancement. To achieve this, the company focuses on developing, manufacturing, and distributing high-quality ingre...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
About the Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipients for pharmaceuti...
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
About the Company : Capital Farma offers a comprehensive range of pharmaceutical solutions. Our API offering includes active ingredients sourced exclusively from top European manufacturers, ensuring t...
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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, Price,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.
PharmaCompass also assists you with knowing the Trimebutine Maleate API Price utilized in the formulation of products. Trimebutine Maleate API Price is not always fixed or binding as the Trimebutine Maleate Price is obtained through a variety of data sources. The Trimebutine Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pfizer Brand of Trimebutine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pfizer Brand of Trimebutine Maleate, including repackagers and relabelers. The FDA regulates Pfizer Brand of Trimebutine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pfizer Brand of Trimebutine Maleate supplier is an individual or a company that provides Pfizer Brand of Trimebutine Maleate active pharmaceutical ingredient (API) or Pfizer Brand of Trimebutine Maleate finished formulations upon request. The Pfizer Brand of Trimebutine Maleate suppliers may include Pfizer Brand of Trimebutine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Pfizer Brand of Trimebutine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pfizer Brand of Trimebutine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Pfizer Brand of Trimebutine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Pfizer Brand of Trimebutine Maleate DMFs exist exist since differing nations have different regulations, such as Pfizer Brand of Trimebutine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pfizer Brand of Trimebutine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Pfizer Brand of Trimebutine Maleate USDMF includes data on Pfizer Brand of Trimebutine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pfizer Brand of Trimebutine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate Drug Master File in Japan (Pfizer Brand of Trimebutine Maleate JDMF) empowers Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate Drug Master File in Korea (Pfizer Brand of Trimebutine Maleate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pfizer Brand of Trimebutine Maleate. The MFDS reviews the Pfizer Brand of Trimebutine Maleate KDMF as part of the drug registration process and uses the information provided in the Pfizer Brand of Trimebutine Maleate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pfizer Brand of Trimebutine Maleate suppliers with KDMF on PharmaCompass.
A Pfizer Brand of Trimebutine Maleate CEP of the European Pharmacopoeia monograph is often referred to as a Pfizer Brand of Trimebutine Maleate Certificate of Suitability (COS). The purpose of a Pfizer Brand of Trimebutine Maleate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pfizer Brand of Trimebutine Maleate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pfizer Brand of Trimebutine Maleate to their clients by showing that a Pfizer Brand of Trimebutine Maleate CEP has been issued for it. The manufacturer submits a Pfizer Brand of Trimebutine Maleate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pfizer Brand of Trimebutine Maleate CEP holder for the record. Additionally, the data presented in the Pfizer Brand of Trimebutine Maleate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pfizer Brand of Trimebutine Maleate DMF.
A Pfizer Brand of Trimebutine Maleate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate suppliers with CEP (COS) on PharmaCompass.
A Pfizer Brand of Trimebutine Maleate written confirmation (Pfizer Brand of Trimebutine Maleate WC) is an official document issued by a regulatory agency to a Pfizer Brand of Trimebutine Maleate manufacturer, verifying that the manufacturing facility of a Pfizer Brand of Trimebutine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pfizer Brand of Trimebutine Maleate APIs or Pfizer Brand of Trimebutine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Pfizer Brand of Trimebutine Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pfizer Brand of Trimebutine Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pfizer Brand of Trimebutine Maleate suppliers with NDC on PharmaCompass.
Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate 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 Pfizer Brand of Trimebutine Maleate GMP manufacturer or Pfizer Brand of Trimebutine Maleate GMP API supplier for your needs.
A Pfizer Brand of Trimebutine Maleate CoA (Certificate of Analysis) is a formal document that attests to Pfizer Brand of Trimebutine Maleate's compliance with Pfizer Brand of Trimebutine Maleate specifications and serves as a tool for batch-level quality control.
Pfizer Brand of Trimebutine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Pfizer Brand of Trimebutine Maleate 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.
Pfizer Brand of Trimebutine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Pfizer Brand of Trimebutine Maleate EP), Pfizer Brand of Trimebutine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pfizer Brand of Trimebutine Maleate USP).
