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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17075
Submission : 2004-01-07
Status :
Type : II
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
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PharmaCompass offers a list of Rasagiline 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 Rasagiline Mesylate manufacturer or Rasagiline Mesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rasagiline Mesylate manufacturer or Rasagiline Mesylate supplier.
PharmaCompass also assists you with knowing the Rasagiline Mesylate API Price utilized in the formulation of products. Rasagiline Mesylate API Price is not always fixed or binding as the Rasagiline Mesylate Price is obtained through a variety of data sources. The Rasagiline Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TVP 1012 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TVP 1012, including repackagers and relabelers. The FDA regulates TVP 1012 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TVP 1012 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 TVP 1012 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TVP 1012 supplier is an individual or a company that provides TVP 1012 active pharmaceutical ingredient (API) or TVP 1012 finished formulations upon request. The TVP 1012 suppliers may include TVP 1012 API manufacturers, exporters, distributors and traders.
click here to find a list of TVP 1012 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TVP 1012 DMF (Drug Master File) is a document detailing the whole manufacturing process of TVP 1012 active pharmaceutical ingredient (API) in detail. Different forms of TVP 1012 DMFs exist exist since differing nations have different regulations, such as TVP 1012 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TVP 1012 DMF submitted to regulatory agencies in the US is known as a USDMF. TVP 1012 USDMF includes data on TVP 1012's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TVP 1012 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TVP 1012 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 TVP 1012 Drug Master File in Korea (TVP 1012 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TVP 1012. The MFDS reviews the TVP 1012 KDMF as part of the drug registration process and uses the information provided in the TVP 1012 KDMF to evaluate the safety and efficacy of the drug.
After submitting a TVP 1012 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 TVP 1012 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of TVP 1012 suppliers with KDMF on PharmaCompass.
A TVP 1012 written confirmation (TVP 1012 WC) is an official document issued by a regulatory agency to a TVP 1012 manufacturer, verifying that the manufacturing facility of a TVP 1012 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TVP 1012 APIs or TVP 1012 finished pharmaceutical products to another nation, regulatory agencies frequently require a TVP 1012 WC (written confirmation) as part of the regulatory process.
click here to find a list of TVP 1012 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 TVP 1012 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TVP 1012 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 TVP 1012 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 TVP 1012 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TVP 1012 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TVP 1012 suppliers with NDC on PharmaCompass.
TVP 1012 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 TVP 1012 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 TVP 1012 GMP manufacturer or TVP 1012 GMP API supplier for your needs.
A TVP 1012 CoA (Certificate of Analysis) is a formal document that attests to TVP 1012's compliance with TVP 1012 specifications and serves as a tool for batch-level quality control.
TVP 1012 CoA mostly includes findings from lab analyses of a specific batch. For each TVP 1012 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.
TVP 1012 may be tested according to a variety of international standards, such as European Pharmacopoeia (TVP 1012 EP), TVP 1012 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TVP 1012 USP).
