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API SUPPLIERS
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
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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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Cardopax Retard
Dosage Form : Prolonged-Release Tablet
Dosage Strength : 40mg
Packaging :
Approval Date : 07-02-1985
Application Number : 28101184184
Regulatory Info : Prescription
Registration Country : Denmark
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DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12093
DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12093
DOSAGE - TABLET;ORAL - 30MG **Federal Registe...DOSAGE - TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12093
DOSAGE - TABLET;ORAL - 40MG
USFDA APPLICATION NUMBER - 12093
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 12093
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG
USFDA APPLICATION NUMBER - 19790
DOSAGE - TABLET;ORAL - 37.5MG;20MG
USFDA APPLICATION NUMBER - 20727
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Coating Systems & Additives
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
Pharmacopoeia Ref : NA
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Brand Name : Polyethylene Glycol 400
Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Isosorbide Dinitrate 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 Isosorbide Dinitrate manufacturer or Isosorbide Dinitrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isosorbide Dinitrate manufacturer or Isosorbide Dinitrate supplier.
A Flindix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flindix, including repackagers and relabelers. The FDA regulates Flindix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flindix 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 Flindix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Flindix supplier is an individual or a company that provides Flindix active pharmaceutical ingredient (API) or Flindix finished formulations upon request. The Flindix suppliers may include Flindix API manufacturers, exporters, distributors and traders.
click here to find a list of Flindix suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Flindix DMF (Drug Master File) is a document detailing the whole manufacturing process of Flindix active pharmaceutical ingredient (API) in detail. Different forms of Flindix DMFs exist exist since differing nations have different regulations, such as Flindix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flindix DMF submitted to regulatory agencies in the US is known as a USDMF. Flindix USDMF includes data on Flindix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flindix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flindix 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 Flindix Drug Master File in Japan (Flindix JDMF) empowers Flindix 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 Flindix JDMF during the approval evaluation for pharmaceutical products. At the time of Flindix 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 Flindix 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 Flindix Drug Master File in Korea (Flindix KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Flindix. The MFDS reviews the Flindix KDMF as part of the drug registration process and uses the information provided in the Flindix KDMF to evaluate the safety and efficacy of the drug.
After submitting a Flindix 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 Flindix API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Flindix suppliers with KDMF on PharmaCompass.
A Flindix CEP of the European Pharmacopoeia monograph is often referred to as a Flindix Certificate of Suitability (COS). The purpose of a Flindix CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Flindix EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Flindix to their clients by showing that a Flindix CEP has been issued for it. The manufacturer submits a Flindix CEP (COS) as part of the market authorization procedure, and it takes on the role of a Flindix CEP holder for the record. Additionally, the data presented in the Flindix CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Flindix DMF.
A Flindix CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flindix 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 Flindix suppliers with CEP (COS) 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 Flindix as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Flindix 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 Flindix 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 Flindix and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Flindix NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Flindix suppliers with NDC on PharmaCompass.
Flindix 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 Flindix GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Flindix GMP manufacturer or Flindix GMP API supplier for your needs.
A Flindix CoA (Certificate of Analysis) is a formal document that attests to Flindix's compliance with Flindix specifications and serves as a tool for batch-level quality control.
Flindix CoA mostly includes findings from lab analyses of a specific batch. For each Flindix 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.
Flindix may be tested according to a variety of international standards, such as European Pharmacopoeia (Flindix EP), Flindix JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Flindix USP).
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