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API SUPPLIERS
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USDMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-08
Pay. Date : 2013-01-16
DMF Number : 24798
Submission : 2011-03-23
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23590
Submission : 2010-03-01
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21123
Submission : 2007-12-11
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-17
Pay. Date : 2015-09-28
DMF Number : 28088
Submission : 2015-09-29
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2012-11-09
DMF Number : 23332
Submission : 2009-12-03
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21749
Submission : 2008-07-01
Status :
Type : II
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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- EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Palonosetron Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Palonosetron Hydrochloride, including repackagers and relabelers. The FDA regulates Palonosetron Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Palonosetron Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Palonosetron Hydrochloride supplier is an individual or a company that provides Palonosetron Hydrochloride active pharmaceutical ingredient (API) or Palonosetron Hydrochloride finished formulations upon request. The Palonosetron Hydrochloride suppliers may include Palonosetron Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Palonosetron Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Palonosetron Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Palonosetron Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Palonosetron Hydrochloride DMFs exist exist since differing nations have different regulations, such as Palonosetron Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Palonosetron Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Palonosetron Hydrochloride USDMF includes data on Palonosetron Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Palonosetron Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Palonosetron Hydrochloride 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 Hydrochloride Drug Master File in Japan (Palonosetron Hydrochloride JDMF) empowers Palonosetron Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Palonosetron Hydrochloride 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 Hydrochloride 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 Hydrochloride Drug Master File in Korea (Palonosetron Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Palonosetron Hydrochloride. The MFDS reviews the Palonosetron Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Palonosetron Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Palonosetron Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Palonosetron Hydrochloride suppliers with KDMF on PharmaCompass.
A Palonosetron Hydrochloride written confirmation (Palonosetron Hydrochloride WC) is an official document issued by a regulatory agency to a Palonosetron Hydrochloride manufacturer, verifying that the manufacturing facility of a Palonosetron Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Palonosetron Hydrochloride APIs or Palonosetron Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Palonosetron Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Palonosetron Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Palonosetron Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Palonosetron Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Palonosetron Hydrochloride suppliers with NDC on PharmaCompass.
Palonosetron Hydrochloride 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 Hydrochloride 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 Palonosetron Hydrochloride GMP manufacturer or Palonosetron Hydrochloride GMP API supplier for your needs.
A Palonosetron Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Palonosetron Hydrochloride's compliance with Palonosetron Hydrochloride specifications and serves as a tool for batch-level quality control.
Palonosetron Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Palonosetron Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Palonosetron Hydrochloride EP), Palonosetron Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Palonosetron Hydrochloride USP).
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