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API SUPPLIERS
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USDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36114
Submission : 2021-07-31
Status :
Type : II
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39226
Submission : 2024-01-08
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Anlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.
CAS Number : CAS-68767-14-6
End Use API : Loxoprofen Sodium
About The Company : Anlon Healthcare is a research-intensive pharmaceutical manufacturer based in Rajkot, specializing in high-quality bulk drugs and intermediates. With global rec...
Anlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.
Methyl 2-oxocyclopentanecarboxylate (Me2CPC)
CAS Number : CAS-10472-24-9
End Use API : Loxoprofen Sodium
About The Company : Anlon Healthcare is a research-intensive pharmaceutical manufacturer based in Rajkot, specializing in high-quality bulk drugs and intermediates. With global rec...
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
1H-Pyrazole-5-carboxylic acid, 4-chloro-3-ethyl-1...
CAS Number : 127892-62-0
End Use API : Loxoprofen Sodium
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
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ABOUT THIS PAGE
39
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 Loxoprofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loxoprofen, including repackagers and relabelers. The FDA regulates Loxoprofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loxoprofen 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 Loxoprofen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loxoprofen supplier is an individual or a company that provides Loxoprofen active pharmaceutical ingredient (API) or Loxoprofen finished formulations upon request. The Loxoprofen suppliers may include Loxoprofen API manufacturers, exporters, distributors and traders.
click here to find a list of Loxoprofen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Loxoprofen DMF (Drug Master File) is a document detailing the whole manufacturing process of Loxoprofen active pharmaceutical ingredient (API) in detail. Different forms of Loxoprofen DMFs exist exist since differing nations have different regulations, such as Loxoprofen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Loxoprofen DMF submitted to regulatory agencies in the US is known as a USDMF. Loxoprofen USDMF includes data on Loxoprofen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Loxoprofen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Loxoprofen 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 Loxoprofen Drug Master File in Japan (Loxoprofen JDMF) empowers Loxoprofen 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 Loxoprofen JDMF during the approval evaluation for pharmaceutical products. At the time of Loxoprofen 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 Loxoprofen 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 Loxoprofen Drug Master File in Korea (Loxoprofen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Loxoprofen. The MFDS reviews the Loxoprofen KDMF as part of the drug registration process and uses the information provided in the Loxoprofen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Loxoprofen 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 Loxoprofen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Loxoprofen suppliers with KDMF on PharmaCompass.
A Loxoprofen written confirmation (Loxoprofen WC) is an official document issued by a regulatory agency to a Loxoprofen manufacturer, verifying that the manufacturing facility of a Loxoprofen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Loxoprofen APIs or Loxoprofen finished pharmaceutical products to another nation, regulatory agencies frequently require a Loxoprofen WC (written confirmation) as part of the regulatory process.
click here to find a list of Loxoprofen 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 Loxoprofen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Loxoprofen 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 Loxoprofen 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 Loxoprofen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Loxoprofen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Loxoprofen suppliers with NDC on PharmaCompass.
Loxoprofen 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 Loxoprofen 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 Loxoprofen GMP manufacturer or Loxoprofen GMP API supplier for your needs.
A Loxoprofen CoA (Certificate of Analysis) is a formal document that attests to Loxoprofen's compliance with Loxoprofen specifications and serves as a tool for batch-level quality control.
Loxoprofen CoA mostly includes findings from lab analyses of a specific batch. For each Loxoprofen 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.
Loxoprofen may be tested according to a variety of international standards, such as European Pharmacopoeia (Loxoprofen EP), Loxoprofen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Loxoprofen USP).
