X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
61
PharmaCompass offers a list of Selegiline Hydrochloride 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 Selegiline Hydrochloride manufacturer or Selegiline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Selegiline Hydrochloride manufacturer or Selegiline Hydrochloride supplier.
PharmaCompass also assists you with knowing the Selegiline Hydrochloride API Price utilized in the formulation of products. Selegiline Hydrochloride API Price is not always fixed or binding as the Selegiline Hydrochloride Price is obtained through a variety of data sources. The Selegiline Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Selegiline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selegiline, including repackagers and relabelers. The FDA regulates Selegiline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selegiline 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 Selegiline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Selegiline supplier is an individual or a company that provides Selegiline active pharmaceutical ingredient (API) or Selegiline finished formulations upon request. The Selegiline suppliers may include Selegiline API manufacturers, exporters, distributors and traders.
click here to find a list of Selegiline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Selegiline DMF (Drug Master File) is a document detailing the whole manufacturing process of Selegiline active pharmaceutical ingredient (API) in detail. Different forms of Selegiline DMFs exist exist since differing nations have different regulations, such as Selegiline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Selegiline DMF submitted to regulatory agencies in the US is known as a USDMF. Selegiline USDMF includes data on Selegiline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Selegiline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Selegiline 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 Selegiline Drug Master File in Japan (Selegiline JDMF) empowers Selegiline 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 Selegiline JDMF during the approval evaluation for pharmaceutical products. At the time of Selegiline 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 Selegiline 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 Selegiline Drug Master File in Korea (Selegiline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Selegiline. The MFDS reviews the Selegiline KDMF as part of the drug registration process and uses the information provided in the Selegiline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Selegiline 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 Selegiline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Selegiline suppliers with KDMF on PharmaCompass.
A Selegiline CEP of the European Pharmacopoeia monograph is often referred to as a Selegiline Certificate of Suitability (COS). The purpose of a Selegiline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Selegiline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Selegiline to their clients by showing that a Selegiline CEP has been issued for it. The manufacturer submits a Selegiline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Selegiline CEP holder for the record. Additionally, the data presented in the Selegiline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Selegiline DMF.
A Selegiline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Selegiline 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 Selegiline suppliers with CEP (COS) on PharmaCompass.
A Selegiline written confirmation (Selegiline WC) is an official document issued by a regulatory agency to a Selegiline manufacturer, verifying that the manufacturing facility of a Selegiline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Selegiline APIs or Selegiline finished pharmaceutical products to another nation, regulatory agencies frequently require a Selegiline WC (written confirmation) as part of the regulatory process.
click here to find a list of Selegiline 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 Selegiline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Selegiline 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 Selegiline 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 Selegiline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Selegiline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Selegiline suppliers with NDC on PharmaCompass.
Selegiline 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 Selegiline 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 Selegiline GMP manufacturer or Selegiline GMP API supplier for your needs.
A Selegiline CoA (Certificate of Analysis) is a formal document that attests to Selegiline's compliance with Selegiline specifications and serves as a tool for batch-level quality control.
Selegiline CoA mostly includes findings from lab analyses of a specific batch. For each Selegiline 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.
Selegiline may be tested according to a variety of international standards, such as European Pharmacopoeia (Selegiline EP), Selegiline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Selegiline USP).
Market Place
