X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
39
PharmaCompass offers a list of Baclofen 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 Baclofen manufacturer or Baclofen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Baclofen manufacturer or Baclofen supplier.
PharmaCompass also assists you with knowing the Baclofen API Price utilized in the formulation of products. Baclofen API Price is not always fixed or binding as the Baclofen Price is obtained through a variety of data sources. The Baclofen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MolPort-002-051-370 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-002-051-370, including repackagers and relabelers. The FDA regulates MolPort-002-051-370 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-002-051-370 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 MolPort-002-051-370 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MolPort-002-051-370 supplier is an individual or a company that provides MolPort-002-051-370 active pharmaceutical ingredient (API) or MolPort-002-051-370 finished formulations upon request. The MolPort-002-051-370 suppliers may include MolPort-002-051-370 API manufacturers, exporters, distributors and traders.
click here to find a list of MolPort-002-051-370 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MolPort-002-051-370 DMF (Drug Master File) is a document detailing the whole manufacturing process of MolPort-002-051-370 active pharmaceutical ingredient (API) in detail. Different forms of MolPort-002-051-370 DMFs exist exist since differing nations have different regulations, such as MolPort-002-051-370 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MolPort-002-051-370 DMF submitted to regulatory agencies in the US is known as a USDMF. MolPort-002-051-370 USDMF includes data on MolPort-002-051-370's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MolPort-002-051-370 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MolPort-002-051-370 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 MolPort-002-051-370 Drug Master File in Japan (MolPort-002-051-370 JDMF) empowers MolPort-002-051-370 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 MolPort-002-051-370 JDMF during the approval evaluation for pharmaceutical products. At the time of MolPort-002-051-370 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 MolPort-002-051-370 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 MolPort-002-051-370 Drug Master File in Korea (MolPort-002-051-370 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MolPort-002-051-370. The MFDS reviews the MolPort-002-051-370 KDMF as part of the drug registration process and uses the information provided in the MolPort-002-051-370 KDMF to evaluate the safety and efficacy of the drug.
After submitting a MolPort-002-051-370 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 MolPort-002-051-370 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MolPort-002-051-370 suppliers with KDMF on PharmaCompass.
A MolPort-002-051-370 CEP of the European Pharmacopoeia monograph is often referred to as a MolPort-002-051-370 Certificate of Suitability (COS). The purpose of a MolPort-002-051-370 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MolPort-002-051-370 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MolPort-002-051-370 to their clients by showing that a MolPort-002-051-370 CEP has been issued for it. The manufacturer submits a MolPort-002-051-370 CEP (COS) as part of the market authorization procedure, and it takes on the role of a MolPort-002-051-370 CEP holder for the record. Additionally, the data presented in the MolPort-002-051-370 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MolPort-002-051-370 DMF.
A MolPort-002-051-370 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MolPort-002-051-370 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 MolPort-002-051-370 suppliers with CEP (COS) on PharmaCompass.
A MolPort-002-051-370 written confirmation (MolPort-002-051-370 WC) is an official document issued by a regulatory agency to a MolPort-002-051-370 manufacturer, verifying that the manufacturing facility of a MolPort-002-051-370 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MolPort-002-051-370 APIs or MolPort-002-051-370 finished pharmaceutical products to another nation, regulatory agencies frequently require a MolPort-002-051-370 WC (written confirmation) as part of the regulatory process.
click here to find a list of MolPort-002-051-370 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 MolPort-002-051-370 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MolPort-002-051-370 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 MolPort-002-051-370 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 MolPort-002-051-370 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MolPort-002-051-370 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MolPort-002-051-370 suppliers with NDC on PharmaCompass.
MolPort-002-051-370 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 MolPort-002-051-370 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 MolPort-002-051-370 GMP manufacturer or MolPort-002-051-370 GMP API supplier for your needs.
A MolPort-002-051-370 CoA (Certificate of Analysis) is a formal document that attests to MolPort-002-051-370's compliance with MolPort-002-051-370 specifications and serves as a tool for batch-level quality control.
MolPort-002-051-370 CoA mostly includes findings from lab analyses of a specific batch. For each MolPort-002-051-370 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.
MolPort-002-051-370 may be tested according to a variety of international standards, such as European Pharmacopoeia (MolPort-002-051-370 EP), MolPort-002-051-370 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MolPort-002-051-370 USP).
Market Place
