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API SUPPLIERS
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40468
Submission : 2024-10-03
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-08
Pay. Date : 2023-07-05
DMF Number : 38210
Submission : 2023-03-28
Status :
Type : II
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
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&...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...
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 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...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns two Gujarat facilities...
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DOSAGE - POWDER;INTRAVENOUS - EQ 115MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22023
DOSAGE - POWDER;INTRAVENOUS - EQ 150MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 150MG BASE/VIAL
USFDA APPLICATION NUMBER - 22023
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Fosaprepitant API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Fosaprepitant manufacturer or Fosaprepitant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fosaprepitant manufacturer or Fosaprepitant supplier.
A Fosaprepitant Dimeglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosaprepitant Dimeglumine, including repackagers and relabelers. The FDA regulates Fosaprepitant Dimeglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Fosaprepitant Dimeglumine supplier is an individual or a company that provides Fosaprepitant Dimeglumine active pharmaceutical ingredient (API) or Fosaprepitant Dimeglumine finished formulations upon request. The Fosaprepitant Dimeglumine suppliers may include Fosaprepitant Dimeglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Fosaprepitant Dimeglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Fosaprepitant Dimeglumine DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosaprepitant Dimeglumine active pharmaceutical ingredient (API) in detail. Different forms of Fosaprepitant Dimeglumine DMFs exist exist since differing nations have different regulations, such as Fosaprepitant Dimeglumine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosaprepitant Dimeglumine DMF submitted to regulatory agencies in the US is known as a USDMF. Fosaprepitant Dimeglumine USDMF includes data on Fosaprepitant Dimeglumine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosaprepitant Dimeglumine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine Drug Master File in Japan (Fosaprepitant Dimeglumine JDMF) empowers Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine JDMF during the approval evaluation for pharmaceutical products. At the time of Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine Drug Master File in Korea (Fosaprepitant Dimeglumine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fosaprepitant Dimeglumine. The MFDS reviews the Fosaprepitant Dimeglumine KDMF as part of the drug registration process and uses the information provided in the Fosaprepitant Dimeglumine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fosaprepitant Dimeglumine suppliers with KDMF on PharmaCompass.
A Fosaprepitant Dimeglumine written confirmation (Fosaprepitant Dimeglumine WC) is an official document issued by a regulatory agency to a Fosaprepitant Dimeglumine manufacturer, verifying that the manufacturing facility of a Fosaprepitant Dimeglumine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fosaprepitant Dimeglumine APIs or Fosaprepitant Dimeglumine finished pharmaceutical products to another nation, regulatory agencies frequently require a Fosaprepitant Dimeglumine WC (written confirmation) as part of the regulatory process.
click here to find a list of Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fosaprepitant Dimeglumine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fosaprepitant Dimeglumine suppliers with NDC on PharmaCompass.
Fosaprepitant Dimeglumine 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 Fosaprepitant Dimeglumine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Fosaprepitant Dimeglumine GMP manufacturer or Fosaprepitant Dimeglumine GMP API supplier for your needs.
A Fosaprepitant Dimeglumine CoA (Certificate of Analysis) is a formal document that attests to Fosaprepitant Dimeglumine's compliance with Fosaprepitant Dimeglumine specifications and serves as a tool for batch-level quality control.
Fosaprepitant Dimeglumine CoA mostly includes findings from lab analyses of a specific batch. For each Fosaprepitant Dimeglumine 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.
Fosaprepitant Dimeglumine may be tested according to a variety of international standards, such as European Pharmacopoeia (Fosaprepitant Dimeglumine EP), Fosaprepitant Dimeglumine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fosaprepitant Dimeglumine USP).
