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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16317
Submission : 2002-12-13
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-23
Pay. Date : 2015-09-09
DMF Number : 15436
Submission : 2001-05-15
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17053
Submission : 2003-12-22
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15642
Submission : 2001-10-01
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Inke S.A: APIs manufacturing plant.
Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2005-056 - Rev 00
Status : Valid
Issue Date : 2012-05-24
Type : Chemical
Substance Number : 2016
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2005-071 - Rev 06
Status : Valid
Issue Date : 2023-05-23
Type : Chemical
Substance Number : 2016
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Ondansetron hydrochloride hydrate
Registration Number : 302MF10019
Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA
Initial Date of Registration : 2020-01-31
Latest Date of Registration : 2020-01-31
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Ondansetron hydrochloride hydrate
Registration Number : 221MF10130
Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA
Initial Date of Registration : 2009-06-30
Latest Date of Registration : 2016-02-18
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registration Number : 307MF10012
Registrant's Address : 13 Pallagi u(´)t, Debrecen, 4042-Hungary
Initial Date of Registration : 2025-01-09
Latest Date of Registration : 2025-01-09
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Ondansetron hydrochloride (Teva)
Registration Number : 219MF10022
Registrant's Address : 13 Pallagi u(´)t, Debrecen, 4042-Hungary
Initial Date of Registration : 2007-01-22
Latest Date of Registration : 2017-05-16
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-05-27
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043
Address of the Firm : Chemical Technical Operations ? Unit V, Peddadevulapally Village, Tripuraram Man...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-05-27
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043
Address of the Firm : Chemical Technical Operations ? Unit V, Peddadevulapally Village, Tripuraram Man...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Ondansetron Hydrochloride Dihyrate Ph.Eur
Date of Issue : 2022-05-27
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043
Address of the Firm : Chemical Technical Operations ? Unit V, Peddadevulapally Village, Tripuraram Man...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-05-27
Valid Till : 2025-06-04
Written Confirmation Number : WC-0043
Address of the Firm : Chemical Technical Operations ? Unit V, Peddadevulapally Village, Tripuraram Man...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Ondansetron hydrochloride hydrate
Registrant Name : Sangjin Corporation
Registration Date : 2021-06-22
Registration Number : 20210426-47-B-440-20(1)
Manufacturer Name : Dr. Reddy's Laboratories Ltd...
Manufacturer Address : Peddadevulapally Village, Tripuraram Mandal, Nalgonda District - 508 207, Telangana S...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Ondansetron hydrochloride hydrate
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2021-04-26
Registration Number : 20210426-47-B-440-20
Manufacturer Name : Dr. Reddy's Laboratories Ltd...
Manufacturer Address : Chemical Technical Operations - Unit V Peddadevulapally Village, Tripuraram Mandal, N...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
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...
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
About the Company : Emay Pharmaceuticals Pvt Ltd functions as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. As a GMP-approved API manufacturing company, we boast over three decades...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...
Venkar Chemicals – WHO-GMP & ISO Certified API Experts Delivering Global Standards.
About the Company : Venkar Chemicals Pvt. Ltd. is a WHO-GMP, ISO 9001:2008, and ISO 14000:2004 certified company and a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediate...
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API Imports and Exports
INTERMEDIATE SUPPLIERS
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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Ondansetron HCl
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Ondansetron Hydrochlor...
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
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DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20007
DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20103
DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20103
DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20103
DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML **Fe...DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20605
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REF. STANDARDS & IMPURITIES
USP
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
CAS Number : 99614-14-9
Quantity Per Vial :
Price ($) : 950
Catalog Number : 1A08630
Current Lot :
Previous Lot :
NDC Code :
ABOUT THIS PAGE
43
PharmaCompass offers a list of Ondansetron Hydrochloride 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 Ondansetron Hydrochloride manufacturer or Ondansetron Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ondansetron Hydrochloride manufacturer or Ondansetron Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ondansetron Hydrochloride API Price utilized in the formulation of products. Ondansetron Hydrochloride API Price is not always fixed or binding as the Ondansetron Hydrochloride Price is obtained through a variety of data sources. The Ondansetron Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ondansetron Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ondansetron Hydrochloride, including repackagers and relabelers. The FDA regulates Ondansetron Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ondansetron 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 Ondansetron Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ondansetron Hydrochloride supplier is an individual or a company that provides Ondansetron Hydrochloride active pharmaceutical ingredient (API) or Ondansetron Hydrochloride finished formulations upon request. The Ondansetron Hydrochloride suppliers may include Ondansetron Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ondansetron Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ondansetron Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ondansetron Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ondansetron Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ondansetron Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ondansetron Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ondansetron Hydrochloride USDMF includes data on Ondansetron Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ondansetron Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ondansetron 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 Ondansetron Hydrochloride Drug Master File in Japan (Ondansetron Hydrochloride JDMF) empowers Ondansetron 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 Ondansetron Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ondansetron 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 Ondansetron 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 Ondansetron Hydrochloride Drug Master File in Korea (Ondansetron Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ondansetron Hydrochloride. The MFDS reviews the Ondansetron Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Ondansetron Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ondansetron 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 Ondansetron Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ondansetron Hydrochloride suppliers with KDMF on PharmaCompass.
A Ondansetron Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Ondansetron Hydrochloride Certificate of Suitability (COS). The purpose of a Ondansetron Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ondansetron Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ondansetron Hydrochloride to their clients by showing that a Ondansetron Hydrochloride CEP has been issued for it. The manufacturer submits a Ondansetron Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ondansetron Hydrochloride CEP holder for the record. Additionally, the data presented in the Ondansetron Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ondansetron Hydrochloride DMF.
A Ondansetron Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ondansetron Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Ondansetron Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Ondansetron Hydrochloride written confirmation (Ondansetron Hydrochloride WC) is an official document issued by a regulatory agency to a Ondansetron Hydrochloride manufacturer, verifying that the manufacturing facility of a Ondansetron Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ondansetron Hydrochloride APIs or Ondansetron Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Ondansetron Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Ondansetron 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 Ondansetron Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ondansetron 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 Ondansetron 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 Ondansetron Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ondansetron Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ondansetron Hydrochloride suppliers with NDC on PharmaCompass.
Ondansetron 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 Ondansetron 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 Ondansetron Hydrochloride GMP manufacturer or Ondansetron Hydrochloride GMP API supplier for your needs.
A Ondansetron Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Ondansetron Hydrochloride's compliance with Ondansetron Hydrochloride specifications and serves as a tool for batch-level quality control.
Ondansetron Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Ondansetron 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.
Ondansetron Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Ondansetron Hydrochloride EP), Ondansetron Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ondansetron Hydrochloride USP).
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