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API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
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
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41529
Submission : 2025-03-17
Status :
Type : II
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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...
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...
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
About the Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities ar...
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 Niraparib 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 Niraparib Tosylate manufacturer or Niraparib Tosylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Niraparib Tosylate manufacturer or Niraparib Tosylate supplier.
PharmaCompass also assists you with knowing the Niraparib Tosylate API Price utilized in the formulation of products. Niraparib Tosylate API Price is not always fixed or binding as the Niraparib Tosylate Price is obtained through a variety of data sources. The Niraparib Tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Niraparib Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niraparib Tosylate, including repackagers and relabelers. The FDA regulates Niraparib Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niraparib 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 Niraparib Tosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niraparib Tosylate supplier is an individual or a company that provides Niraparib Tosylate active pharmaceutical ingredient (API) or Niraparib Tosylate finished formulations upon request. The Niraparib Tosylate suppliers may include Niraparib Tosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Niraparib Tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Niraparib Tosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Niraparib Tosylate active pharmaceutical ingredient (API) in detail. Different forms of Niraparib Tosylate DMFs exist exist since differing nations have different regulations, such as Niraparib Tosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Niraparib Tosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Niraparib Tosylate USDMF includes data on Niraparib Tosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Niraparib Tosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Niraparib Tosylate suppliers with USDMF on PharmaCompass.
A Niraparib Tosylate written confirmation (Niraparib Tosylate WC) is an official document issued by a regulatory agency to a Niraparib Tosylate manufacturer, verifying that the manufacturing facility of a Niraparib Tosylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Niraparib Tosylate APIs or Niraparib Tosylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Niraparib Tosylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Niraparib 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 Niraparib Tosylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Niraparib 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 Niraparib 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 Niraparib Tosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Niraparib Tosylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Niraparib Tosylate suppliers with NDC on PharmaCompass.
Niraparib 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 Niraparib 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 Niraparib Tosylate GMP manufacturer or Niraparib Tosylate GMP API supplier for your needs.
A Niraparib Tosylate CoA (Certificate of Analysis) is a formal document that attests to Niraparib Tosylate's compliance with Niraparib Tosylate specifications and serves as a tool for batch-level quality control.
Niraparib Tosylate CoA mostly includes findings from lab analyses of a specific batch. For each Niraparib 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.
Niraparib Tosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Niraparib Tosylate EP), Niraparib Tosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Niraparib Tosylate USP).
