Synopsis
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JDMF
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VMF
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EDQM
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USP
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JP
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DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
Jai Radhe Sales is your partner for all your sourcing needs.
With Virupaksha, you get a quality product with on-time delivery.
EU-WC
ASMF 
AMI Lifesciences is Driven by Chemistry. Powered by People.
EU-WC
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
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USDMF
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With Virupaksha, you get a quality product with on-time delivery.
Tapentadol Hydrochloride IP/EP
Date of Issue : 2024-01-15
Valid Till : 2027-01-15
Written Confirmation Number : WC-0575
Address of the Firm : Plot No. 30 to 33 Phase-l, IDA Pashamylaram Patancheru IDA Pashamylaram, Sangare...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City Karakhadi -39145...
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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
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Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : Solution
Dosage Strength : 4MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : Solution
Dosage Strength : 20MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 200533
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 200533
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 200533
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE
USFDA APPLICATION NUMBER - 200533
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 200533
DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/ML **Fe...DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 203794
DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 22304
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 22304
DOSAGE - TABLET;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 22304
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ABOUT THIS PAGE
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PharmaCompass offers a list of Tapentadol 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 Tapentadol manufacturer or Tapentadol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tapentadol manufacturer or Tapentadol supplier.
PharmaCompass also assists you with knowing the Tapentadol API Price utilized in the formulation of products. Tapentadol API Price is not always fixed or binding as the Tapentadol Price is obtained through a variety of data sources. The Tapentadol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tapentadol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tapentadol, including repackagers and relabelers. The FDA regulates Tapentadol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tapentadol 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 Tapentadol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tapentadol supplier is an individual or a company that provides Tapentadol active pharmaceutical ingredient (API) or Tapentadol finished formulations upon request. The Tapentadol suppliers may include Tapentadol API manufacturers, exporters, distributors and traders.
click here to find a list of Tapentadol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tapentadol DMF (Drug Master File) is a document detailing the whole manufacturing process of Tapentadol active pharmaceutical ingredient (API) in detail. Different forms of Tapentadol DMFs exist exist since differing nations have different regulations, such as Tapentadol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tapentadol DMF submitted to regulatory agencies in the US is known as a USDMF. Tapentadol USDMF includes data on Tapentadol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tapentadol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tapentadol suppliers with USDMF 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 Tapentadol Drug Master File in Korea (Tapentadol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tapentadol. The MFDS reviews the Tapentadol KDMF as part of the drug registration process and uses the information provided in the Tapentadol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tapentadol 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 Tapentadol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tapentadol suppliers with KDMF on PharmaCompass.
A Tapentadol CEP of the European Pharmacopoeia monograph is often referred to as a Tapentadol Certificate of Suitability (COS). The purpose of a Tapentadol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tapentadol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tapentadol to their clients by showing that a Tapentadol CEP has been issued for it. The manufacturer submits a Tapentadol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tapentadol CEP holder for the record. Additionally, the data presented in the Tapentadol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tapentadol DMF.
A Tapentadol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tapentadol 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 Tapentadol suppliers with CEP (COS) on PharmaCompass.
A Tapentadol written confirmation (Tapentadol WC) is an official document issued by a regulatory agency to a Tapentadol manufacturer, verifying that the manufacturing facility of a Tapentadol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tapentadol APIs or Tapentadol finished pharmaceutical products to another nation, regulatory agencies frequently require a Tapentadol WC (written confirmation) as part of the regulatory process.
click here to find a list of Tapentadol 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 Tapentadol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tapentadol 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 Tapentadol 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 Tapentadol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tapentadol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tapentadol suppliers with NDC on PharmaCompass.
Tapentadol 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 Tapentadol 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 Tapentadol GMP manufacturer or Tapentadol GMP API supplier for your needs.
A Tapentadol CoA (Certificate of Analysis) is a formal document that attests to Tapentadol's compliance with Tapentadol specifications and serves as a tool for batch-level quality control.
Tapentadol CoA mostly includes findings from lab analyses of a specific batch. For each Tapentadol 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.
Tapentadol may be tested according to a variety of international standards, such as European Pharmacopoeia (Tapentadol EP), Tapentadol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tapentadol USP).
