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API SUPPLIERS
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USDMF
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Perindopril; Indapamidum; Amlodipine
Brand Name : Perindopril Amlodipine Indapamide Zentiva mg
Dosage Form : Tablet
Dosage Strength : 4mg;5mg;1.25mg
Packaging :
Approval Date : 02/07/2021
Application Number : 67958
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Perindopril; Indapamidum; Amlodipine
Brand Name : Perindopril Amlodipin Indapamid Zentiva mg
Dosage Form : Tablet
Dosage Strength : 4mg;10mg;1.25mg
Packaging :
Approval Date : 02/07/2021
Application Number : 67958
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Perindopril; Indapamidum; Amlodipine
Brand Name : Perindopril Amlodipine Indapamid Zentiva mg
Dosage Form : Tablet
Dosage Strength : 8mg;5mg;2.5mg
Packaging :
Approval Date : 02/07/2021
Application Number : 67958
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Perindopril; Indapamidum; Amlodipine
Brand Name : Perindopril Amlodipin Indapamid Zentiva mg
Dosage Form : Tablet
Dosage Strength : 8mg;10mg;2.5mg
Packaging :
Approval Date : 02/07/2021
Application Number : 67958
Regulatory Info : Allowed
Registration Country : Switzerland
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info :
Registration Country : Italy
Brand Name : INDAPAMIDE THINK
Dosage Form : Coated Tablets
Dosage Strength : 2.5 mg
Packaging : 50 UNITS 2.5 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Indapamida Retard Pensa
Dosage Form : Extended-Release Film Coated Tablet
Dosage Strength : 1.5MG
Packaging :
Approval Date : 12-11-2007
Application Number : 69392
Regulatory Info : Authorized
Registration Country : Spain
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Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
Regulatory Info :
Registration Country : Hungary
Bisoprolol Fumarate; Indapamide
Brand Name : Ramipril ; Indapamide ...
Dosage Form : Capsule
Dosage Strength : 5MG; 1.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
Regulatory Info :
Registration Country : Hungary
Bisoprolol Fumarate; Indapamide
Brand Name : Ramipril ; Indapamide ...
Dosage Form : Capsule
Dosage Strength : 10MG; 1.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Since 1980, Octavius Pharma has been empowering lives by delivering trusted healthcare solutions, including DC granules, APIs, and FDFs
Regulatory Info :
Registration Country : India
Brand Name : Indapamide
Dosage Form : DC Granules
Dosage Strength : 1.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Indapamide
Dosage Form : Tablet
Dosage Strength : 2.4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Indapamide
Dosage Form : Tablet
Dosage Strength : 2.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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ABOUT THIS PAGE
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PharmaCompass offers a list of Indapamide 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 Indapamide manufacturer or Indapamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Indapamide manufacturer or Indapamide supplier.
A Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol, including repackagers and relabelers. The FDA regulates Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol supplier is an individual or a company that provides Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol active pharmaceutical ingredient (API) or Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol finished formulations upon request. The Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol suppliers may include Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol API manufacturers, exporters, distributors and traders.
click here to find a list of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol DMF (Drug Master File) is a document detailing the whole manufacturing process of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol active pharmaceutical ingredient (API) in detail. Different forms of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol DMFs exist exist since differing nations have different regulations, such as Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol DMF submitted to regulatory agencies in the US is known as a USDMF. Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol USDMF includes data on Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol Drug Master File in Japan (Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol JDMF) empowers Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol JDMF during the approval evaluation for pharmaceutical products. At the time of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol Drug Master File in Korea (Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol. The MFDS reviews the Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol KDMF as part of the drug registration process and uses the information provided in the Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol suppliers with KDMF on PharmaCompass.
A Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol CEP of the European Pharmacopoeia monograph is often referred to as a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol Certificate of Suitability (COS). The purpose of a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol to their clients by showing that a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol CEP has been issued for it. The manufacturer submits a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol CEP holder for the record. Additionally, the data presented in the Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol DMF.
A Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol suppliers with CEP (COS) on PharmaCompass.
A Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol written confirmation (Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol WC) is an official document issued by a regulatory agency to a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol manufacturer, verifying that the manufacturing facility of a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol APIs or Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol finished pharmaceutical products to another nation, regulatory agencies frequently require a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol WC (written confirmation) as part of the regulatory process.
click here to find a list of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol suppliers with NDC on PharmaCompass.
Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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 Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol GMP manufacturer or Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol GMP API supplier for your needs.
A Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol CoA (Certificate of Analysis) is a formal document that attests to Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol's compliance with Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol specifications and serves as a tool for batch-level quality control.
Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol CoA mostly includes findings from lab analyses of a specific batch. For each Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol 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.
Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol may be tested according to a variety of international standards, such as European Pharmacopoeia (Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol EP), Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Arifon;Fludex;Noranat;Veroxil;Tertensif;Lozol USP).
