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API SUPPLIERS
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USDMF
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2025-05-28
Valid Till : 2028-06-25
Written Confirmation Number : WC-0035
Address of the Firm : Chemical Technical Operations, Unit -Ill, Plot No. 116,Sri Venkateswara Co-opera...
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Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with...
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 ...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and man...
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...
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DOSAGE - CAPSULE;ORAL - 300MG;EQ 0.5MG BASE
USFDA APPLICATION NUMBER - 205718
DOSAGE - SOLUTION;INTRAVENOUS - EQ 0.25MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
USFDA APPLICATION NUMBER - 208109
DOSAGE - POWDER;INTRAVENOUS - EQ 235MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
USFDA APPLICATION NUMBER - 210493
DOSAGE - SOLUTION;INTRAVENOUS - EQ 235MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
USFDA APPLICATION NUMBER - 210493
DOSAGE - INJECTABLE;INTRAVENOUS - EQ 0.075MG ...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21372
DOSAGE - INJECTABLE;INTRAVENOUS - EQ 0.25MG B...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21372
DOSAGE - CAPSULE;ORAL - EQ 0.5MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22233
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ABOUT THIS PAGE
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PharmaCompass offers a list of Palonosetron 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 Palonosetron manufacturer or Palonosetron supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Palonosetron manufacturer or Palonosetron supplier.
A Palonosetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Palonosetron, including repackagers and relabelers. The FDA regulates Palonosetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Palonosetron 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 Palonosetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Palonosetron supplier is an individual or a company that provides Palonosetron active pharmaceutical ingredient (API) or Palonosetron finished formulations upon request. The Palonosetron suppliers may include Palonosetron API manufacturers, exporters, distributors and traders.
click here to find a list of Palonosetron suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Palonosetron DMF (Drug Master File) is a document detailing the whole manufacturing process of Palonosetron active pharmaceutical ingredient (API) in detail. Different forms of Palonosetron DMFs exist exist since differing nations have different regulations, such as Palonosetron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Palonosetron DMF submitted to regulatory agencies in the US is known as a USDMF. Palonosetron USDMF includes data on Palonosetron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Palonosetron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Palonosetron 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 Palonosetron Drug Master File in Japan (Palonosetron JDMF) empowers Palonosetron 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 Palonosetron JDMF during the approval evaluation for pharmaceutical products. At the time of Palonosetron 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 Palonosetron 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 Palonosetron Drug Master File in Korea (Palonosetron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Palonosetron. The MFDS reviews the Palonosetron KDMF as part of the drug registration process and uses the information provided in the Palonosetron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Palonosetron 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 Palonosetron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Palonosetron suppliers with KDMF on PharmaCompass.
A Palonosetron written confirmation (Palonosetron WC) is an official document issued by a regulatory agency to a Palonosetron manufacturer, verifying that the manufacturing facility of a Palonosetron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Palonosetron APIs or Palonosetron finished pharmaceutical products to another nation, regulatory agencies frequently require a Palonosetron WC (written confirmation) as part of the regulatory process.
click here to find a list of Palonosetron 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 Palonosetron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Palonosetron 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 Palonosetron 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 Palonosetron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Palonosetron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Palonosetron suppliers with NDC on PharmaCompass.
Palonosetron 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 Palonosetron GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Palonosetron GMP manufacturer or Palonosetron GMP API supplier for your needs.
A Palonosetron CoA (Certificate of Analysis) is a formal document that attests to Palonosetron's compliance with Palonosetron specifications and serves as a tool for batch-level quality control.
Palonosetron CoA mostly includes findings from lab analyses of a specific batch. For each Palonosetron 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.
Palonosetron may be tested according to a variety of international standards, such as European Pharmacopoeia (Palonosetron EP), Palonosetron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Palonosetron USP).
