Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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FDF Dossiers
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FDA Orange Book
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Europe
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Canada
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Australia
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API SUPPLIERS
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
Maithri Drugs: Dedicated to your API needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
✕ Product Not Available For Sales
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
ApiSyn: From early-phase research and process development to reliable cGMP manufacturing worldwide.
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USDMF
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42043
Submission : 2025-05-31
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
About the Company : Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...
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...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma was established in 1986 and began operating as a fully integrated pharmaceutical company in 1995. The company offers a broad portfolio across multiple therapeutic ca...
ApiSyn: From early-phase research and process development to reliable cGMP manufacturing worldwide.
About the Company : ApiSyn Healthcare, established in 2017, is a vertically integrated manufacturer of APIs & intermediates serving the global pharmaceutical industry. As part of SynZeal Research, a p...
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PharmaCompass offers a list of Xanomeline 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 Xanomeline manufacturer or Xanomeline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Xanomeline manufacturer or Xanomeline supplier.
PharmaCompass also assists you with knowing the Xanomeline API Price utilized in the formulation of products. Xanomeline API Price is not always fixed or binding as the Xanomeline Price is obtained through a variety of data sources. The Xanomeline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A xanomeline tartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of xanomeline tartrate, including repackagers and relabelers. The FDA regulates xanomeline tartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. xanomeline 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 xanomeline tartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A xanomeline tartrate supplier is an individual or a company that provides xanomeline tartrate active pharmaceutical ingredient (API) or xanomeline tartrate finished formulations upon request. The xanomeline tartrate suppliers may include xanomeline tartrate API manufacturers, exporters, distributors and traders.
click here to find a list of xanomeline tartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A xanomeline tartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of xanomeline tartrate active pharmaceutical ingredient (API) in detail. Different forms of xanomeline tartrate DMFs exist exist since differing nations have different regulations, such as xanomeline tartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A xanomeline tartrate DMF submitted to regulatory agencies in the US is known as a USDMF. xanomeline tartrate USDMF includes data on xanomeline tartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The xanomeline tartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of xanomeline tartrate suppliers with USDMF 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 xanomeline tartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for xanomeline 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 xanomeline 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 xanomeline tartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a xanomeline tartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of xanomeline tartrate suppliers with NDC on PharmaCompass.
xanomeline 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 xanomeline 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 xanomeline tartrate GMP manufacturer or xanomeline tartrate GMP API supplier for your needs.
A xanomeline tartrate CoA (Certificate of Analysis) is a formal document that attests to xanomeline tartrate's compliance with xanomeline tartrate specifications and serves as a tool for batch-level quality control.
xanomeline tartrate CoA mostly includes findings from lab analyses of a specific batch. For each xanomeline 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.
xanomeline tartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (xanomeline tartrate EP), xanomeline tartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (xanomeline tartrate USP).
