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API SUPPLIERS
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API Imports and Exports
Drugs in Development
Lead Product(s) : Loxoprofen Sodium,Inapplicable
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Acquired Approval for Manufacturing and Marketing Generic Drugs
Details : Loxoprofen Sodium is a generic version of loxonin tape, which is indicated for the treatment of rheumatoid arthritis and osteoarthritis.
Product Name : Loxoprofen Sodium Tape
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 15, 2024
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PharmaCompass offers a list of Loxoprofen Sodium 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 Loxoprofen Sodium manufacturer or Loxoprofen Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Loxoprofen Sodium manufacturer or Loxoprofen Sodium supplier.
PharmaCompass also assists you with knowing the Loxoprofen Sodium API Price utilized in the formulation of products. Loxoprofen Sodium API Price is not always fixed or binding as the Loxoprofen Sodium Price is obtained through a variety of data sources. The Loxoprofen Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate, including repackagers and relabelers. The FDA regulates Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate supplier is an individual or a company that provides Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate active pharmaceutical ingredient (API) or Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate finished formulations upon request. The Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate suppliers may include Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate DMFs exist exist since differing nations have different regulations, such as Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate USDMF includes data on Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate Drug Master File in Japan (Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate JDMF) empowers Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate Drug Master File in Korea (Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate. The MFDS reviews the Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate KDMF as part of the drug registration process and uses the information provided in the Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate suppliers with KDMF on PharmaCompass.
A Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate written confirmation (Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate WC) is an official document issued by a regulatory agency to a Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate manufacturer, verifying that the manufacturing facility of a Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate APIs or Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate suppliers with NDC on PharmaCompass.
Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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 Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate GMP manufacturer or Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate GMP API supplier for your needs.
A Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate CoA (Certificate of Analysis) is a formal document that attests to Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate's compliance with Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate specifications and serves as a tool for batch-level quality control.
Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate 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.
Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate EP), Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Monosodium 2-(4-((2-oxocyclopentyl)methyl)phenyl)propanoate dihydrate USP).
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