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