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JDMF
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API SUPPLIERS
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-21
Pay. Date : 2023-08-17
DMF Number : 38206
Submission : 2023-03-31
Status :
Type : II
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm : Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District -532409, Andhr...
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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...
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...
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...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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PharmaCompass offers a list of Lumateperone Tosylate 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 Lumateperone Tosylate manufacturer or Lumateperone Tosylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lumateperone Tosylate manufacturer or Lumateperone Tosylate supplier.
PharmaCompass also assists you with knowing the Lumateperone Tosylate API Price utilized in the formulation of products. Lumateperone Tosylate API Price is not always fixed or binding as the Lumateperone Tosylate Price is obtained through a variety of data sources. The Lumateperone Tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lumateperone Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lumateperone Tosylate, including repackagers and relabelers. The FDA regulates Lumateperone Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lumateperone Tosylate 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 Lumateperone Tosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lumateperone Tosylate supplier is an individual or a company that provides Lumateperone Tosylate active pharmaceutical ingredient (API) or Lumateperone Tosylate finished formulations upon request. The Lumateperone Tosylate suppliers may include Lumateperone Tosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Lumateperone Tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lumateperone Tosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lumateperone Tosylate active pharmaceutical ingredient (API) in detail. Different forms of Lumateperone Tosylate DMFs exist exist since differing nations have different regulations, such as Lumateperone Tosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lumateperone Tosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Lumateperone Tosylate USDMF includes data on Lumateperone Tosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lumateperone Tosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lumateperone Tosylate suppliers with USDMF on PharmaCompass.
A Lumateperone Tosylate written confirmation (Lumateperone Tosylate WC) is an official document issued by a regulatory agency to a Lumateperone Tosylate manufacturer, verifying that the manufacturing facility of a Lumateperone Tosylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lumateperone Tosylate APIs or Lumateperone Tosylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Lumateperone Tosylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Lumateperone Tosylate 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 Lumateperone Tosylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lumateperone Tosylate 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 Lumateperone Tosylate 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 Lumateperone Tosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lumateperone Tosylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lumateperone Tosylate suppliers with NDC on PharmaCompass.
Lumateperone Tosylate 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 Lumateperone Tosylate 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 Lumateperone Tosylate GMP manufacturer or Lumateperone Tosylate GMP API supplier for your needs.
A Lumateperone Tosylate CoA (Certificate of Analysis) is a formal document that attests to Lumateperone Tosylate's compliance with Lumateperone Tosylate specifications and serves as a tool for batch-level quality control.
Lumateperone Tosylate CoA mostly includes findings from lab analyses of a specific batch. For each Lumateperone Tosylate 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.
Lumateperone Tosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Lumateperone Tosylate EP), Lumateperone Tosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lumateperone Tosylate USP).
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