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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 Polibutin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polibutin, including repackagers and relabelers. The FDA regulates Polibutin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polibutin 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 Polibutin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polibutin supplier is an individual or a company that provides Polibutin active pharmaceutical ingredient (API) or Polibutin finished formulations upon request. The Polibutin suppliers may include Polibutin API manufacturers, exporters, distributors and traders.
click here to find a list of Polibutin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polibutin DMF (Drug Master File) is a document detailing the whole manufacturing process of Polibutin active pharmaceutical ingredient (API) in detail. Different forms of Polibutin DMFs exist exist since differing nations have different regulations, such as Polibutin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polibutin DMF submitted to regulatory agencies in the US is known as a USDMF. Polibutin USDMF includes data on Polibutin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polibutin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polibutin 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 Polibutin Drug Master File in Japan (Polibutin JDMF) empowers Polibutin 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 Polibutin JDMF during the approval evaluation for pharmaceutical products. At the time of Polibutin 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 Polibutin 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 Polibutin Drug Master File in Korea (Polibutin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Polibutin. The MFDS reviews the Polibutin KDMF as part of the drug registration process and uses the information provided in the Polibutin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Polibutin 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 Polibutin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Polibutin suppliers with KDMF on PharmaCompass.
A Polibutin CEP of the European Pharmacopoeia monograph is often referred to as a Polibutin Certificate of Suitability (COS). The purpose of a Polibutin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Polibutin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Polibutin to their clients by showing that a Polibutin CEP has been issued for it. The manufacturer submits a Polibutin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Polibutin CEP holder for the record. Additionally, the data presented in the Polibutin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Polibutin DMF.
A Polibutin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Polibutin 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 Polibutin 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 Polibutin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Polibutin 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 Polibutin 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 Polibutin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Polibutin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Polibutin suppliers with NDC on PharmaCompass.
Polibutin 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 Polibutin 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 Polibutin GMP manufacturer or Polibutin GMP API supplier for your needs.
A Polibutin CoA (Certificate of Analysis) is a formal document that attests to Polibutin's compliance with Polibutin specifications and serves as a tool for batch-level quality control.
Polibutin CoA mostly includes findings from lab analyses of a specific batch. For each Polibutin 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.
Polibutin may be tested according to a variety of international standards, such as European Pharmacopoeia (Polibutin EP), Polibutin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polibutin USP).
