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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC
Jai Radhe Sales is your partner for all your sourcing needs.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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USDMF
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
A Rasagiline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rasagiline, including repackagers and relabelers. The FDA regulates Rasagiline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rasagiline 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 Rasagiline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rasagiline supplier is an individual or a company that provides Rasagiline active pharmaceutical ingredient (API) or Rasagiline finished formulations upon request. The Rasagiline suppliers may include Rasagiline API manufacturers, exporters, distributors and traders.
click here to find a list of Rasagiline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rasagiline DMF (Drug Master File) is a document detailing the whole manufacturing process of Rasagiline active pharmaceutical ingredient (API) in detail. Different forms of Rasagiline DMFs exist exist since differing nations have different regulations, such as Rasagiline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rasagiline DMF submitted to regulatory agencies in the US is known as a USDMF. Rasagiline USDMF includes data on Rasagiline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rasagiline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rasagiline suppliers with USDMF 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 Rasagiline Drug Master File in Korea (Rasagiline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rasagiline. The MFDS reviews the Rasagiline KDMF as part of the drug registration process and uses the information provided in the Rasagiline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rasagiline 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 Rasagiline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rasagiline suppliers with KDMF on PharmaCompass.
A Rasagiline written confirmation (Rasagiline WC) is an official document issued by a regulatory agency to a Rasagiline manufacturer, verifying that the manufacturing facility of a Rasagiline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rasagiline APIs or Rasagiline finished pharmaceutical products to another nation, regulatory agencies frequently require a Rasagiline WC (written confirmation) as part of the regulatory process.
click here to find a list of Rasagiline 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 Rasagiline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rasagiline 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 Rasagiline 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 Rasagiline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rasagiline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rasagiline suppliers with NDC on PharmaCompass.
Rasagiline 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 Rasagiline 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 Rasagiline GMP manufacturer or Rasagiline GMP API supplier for your needs.
A Rasagiline CoA (Certificate of Analysis) is a formal document that attests to Rasagiline's compliance with Rasagiline specifications and serves as a tool for batch-level quality control.
Rasagiline CoA mostly includes findings from lab analyses of a specific batch. For each Rasagiline 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.
Rasagiline may be tested according to a variety of international standards, such as European Pharmacopoeia (Rasagiline EP), Rasagiline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rasagiline USP).
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