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API SUPPLIERS
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38693
Submission : 2023-08-30
Status :
Type : II
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
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, ...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...
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DOSAGE - TABLET;ORAL - EQ 0.5MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21928
DOSAGE - TABLET;ORAL - EQ 1MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21928
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PharmaCompass offers a list of Varenicline 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 Varenicline manufacturer or Varenicline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Varenicline manufacturer or Varenicline supplier.
PharmaCompass also assists you with knowing the Varenicline API Price utilized in the formulation of products. Varenicline API Price is not always fixed or binding as the Varenicline Price is obtained through a variety of data sources. The Varenicline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Varenicline Tartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Varenicline Tartrate, including repackagers and relabelers. The FDA regulates Varenicline Tartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Varenicline Tartrate 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 Varenicline Tartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Varenicline Tartrate supplier is an individual or a company that provides Varenicline Tartrate active pharmaceutical ingredient (API) or Varenicline Tartrate finished formulations upon request. The Varenicline Tartrate suppliers may include Varenicline Tartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Varenicline Tartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Varenicline Tartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Varenicline Tartrate active pharmaceutical ingredient (API) in detail. Different forms of Varenicline Tartrate DMFs exist exist since differing nations have different regulations, such as Varenicline Tartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Varenicline Tartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Varenicline Tartrate USDMF includes data on Varenicline Tartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Varenicline Tartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Varenicline Tartrate 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 Varenicline Tartrate Drug Master File in Japan (Varenicline Tartrate JDMF) empowers Varenicline Tartrate 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 Varenicline Tartrate JDMF during the approval evaluation for pharmaceutical products. At the time of Varenicline Tartrate 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 Varenicline Tartrate 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 Varenicline Tartrate Drug Master File in Korea (Varenicline Tartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Varenicline Tartrate. The MFDS reviews the Varenicline Tartrate KDMF as part of the drug registration process and uses the information provided in the Varenicline Tartrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Varenicline Tartrate 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 Varenicline Tartrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Varenicline Tartrate suppliers with KDMF on PharmaCompass.
A Varenicline Tartrate written confirmation (Varenicline Tartrate WC) is an official document issued by a regulatory agency to a Varenicline Tartrate manufacturer, verifying that the manufacturing facility of a Varenicline Tartrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Varenicline Tartrate APIs or Varenicline Tartrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Varenicline Tartrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Varenicline Tartrate 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 Varenicline Tartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Varenicline Tartrate 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 Varenicline Tartrate 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 Varenicline Tartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Varenicline Tartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Varenicline Tartrate suppliers with NDC on PharmaCompass.
Varenicline Tartrate 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 Varenicline Tartrate 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 Varenicline Tartrate GMP manufacturer or Varenicline Tartrate GMP API supplier for your needs.
A Varenicline Tartrate CoA (Certificate of Analysis) is a formal document that attests to Varenicline Tartrate's compliance with Varenicline Tartrate specifications and serves as a tool for batch-level quality control.
Varenicline Tartrate CoA mostly includes findings from lab analyses of a specific batch. For each Varenicline Tartrate 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.
Varenicline Tartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Varenicline Tartrate EP), Varenicline Tartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Varenicline Tartrate USP).
