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API SUPPLIERS
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USDMF
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35819
Submission : 2021-03-31
Status :
Type : II
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Maithri Drugs: Dedicated to your API needs.
Date of Issue : 2024-02-12
Valid Till : 2027-02-11
Written Confirmation Number : WC-0407
Address of the Firm : Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally (Village), Gummadidala (Ma...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Registrant Name : Korea Santen Pharmaceutical Co., Ltd.
Registration Date : 2023-11-20
Registration Number : Su139-6-ND
Manufacturer Name : Cayman Chemical Company
Manufacturer Address : 1180 E. Ellsworth Road Ann Arbor, MI 48108 USA
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PharmaCompass offers a list of Netarsudil Mesylate 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 Netarsudil Mesylate manufacturer or Netarsudil Mesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Netarsudil Mesylate manufacturer or Netarsudil Mesylate supplier.
PharmaCompass also assists you with knowing the Netarsudil Mesylate API Price utilized in the formulation of products. Netarsudil Mesylate API Price is not always fixed or binding as the Netarsudil Mesylate Price is obtained through a variety of data sources. The Netarsudil Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Netarsudil Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Netarsudil Mesylate, including repackagers and relabelers. The FDA regulates Netarsudil Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Netarsudil Mesylate 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 Netarsudil Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Netarsudil Mesylate supplier is an individual or a company that provides Netarsudil Mesylate active pharmaceutical ingredient (API) or Netarsudil Mesylate finished formulations upon request. The Netarsudil Mesylate suppliers may include Netarsudil Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Netarsudil Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Netarsudil Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Netarsudil Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Netarsudil Mesylate DMFs exist exist since differing nations have different regulations, such as Netarsudil Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Netarsudil Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Netarsudil Mesylate USDMF includes data on Netarsudil Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Netarsudil Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Netarsudil Mesylate 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 Netarsudil Mesylate Drug Master File in Japan (Netarsudil Mesylate JDMF) empowers Netarsudil Mesylate 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 Netarsudil Mesylate JDMF during the approval evaluation for pharmaceutical products. At the time of Netarsudil Mesylate 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 Netarsudil Mesylate 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 Netarsudil Mesylate Drug Master File in Korea (Netarsudil Mesylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Netarsudil Mesylate. The MFDS reviews the Netarsudil Mesylate KDMF as part of the drug registration process and uses the information provided in the Netarsudil Mesylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Netarsudil Mesylate 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 Netarsudil Mesylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Netarsudil Mesylate suppliers with KDMF on PharmaCompass.
A Netarsudil Mesylate written confirmation (Netarsudil Mesylate WC) is an official document issued by a regulatory agency to a Netarsudil Mesylate manufacturer, verifying that the manufacturing facility of a Netarsudil Mesylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Netarsudil Mesylate APIs or Netarsudil Mesylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Netarsudil Mesylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Netarsudil Mesylate 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 Netarsudil Mesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Netarsudil Mesylate 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 Netarsudil Mesylate 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 Netarsudil Mesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Netarsudil Mesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Netarsudil Mesylate suppliers with NDC on PharmaCompass.
Netarsudil Mesylate 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 Netarsudil Mesylate 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 Netarsudil Mesylate GMP manufacturer or Netarsudil Mesylate GMP API supplier for your needs.
A Netarsudil Mesylate CoA (Certificate of Analysis) is a formal document that attests to Netarsudil Mesylate's compliance with Netarsudil Mesylate specifications and serves as a tool for batch-level quality control.
Netarsudil Mesylate CoA mostly includes findings from lab analyses of a specific batch. For each Netarsudil Mesylate 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.
Netarsudil Mesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Netarsudil Mesylate EP), Netarsudil Mesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Netarsudil Mesylate USP).
