Synopsis
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-05
Pay. Date : 2020-07-30
DMF Number : 21084
Submission : 2008-01-23
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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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 :
Application Number :
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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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 :
Application Number :
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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 Nucynta ER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nucynta ER, including repackagers and relabelers. The FDA regulates Nucynta ER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nucynta ER 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 Nucynta ER manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nucynta ER supplier is an individual or a company that provides Nucynta ER active pharmaceutical ingredient (API) or Nucynta ER finished formulations upon request. The Nucynta ER suppliers may include Nucynta ER API manufacturers, exporters, distributors and traders.
click here to find a list of Nucynta ER suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nucynta ER DMF (Drug Master File) is a document detailing the whole manufacturing process of Nucynta ER active pharmaceutical ingredient (API) in detail. Different forms of Nucynta ER DMFs exist exist since differing nations have different regulations, such as Nucynta ER USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nucynta ER DMF submitted to regulatory agencies in the US is known as a USDMF. Nucynta ER USDMF includes data on Nucynta ER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nucynta ER USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nucynta ER 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 Nucynta ER Drug Master File in Korea (Nucynta ER KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nucynta ER. The MFDS reviews the Nucynta ER KDMF as part of the drug registration process and uses the information provided in the Nucynta ER KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nucynta ER 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 Nucynta ER API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nucynta ER suppliers with KDMF on PharmaCompass.
A Nucynta ER CEP of the European Pharmacopoeia monograph is often referred to as a Nucynta ER Certificate of Suitability (COS). The purpose of a Nucynta ER CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nucynta ER EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nucynta ER to their clients by showing that a Nucynta ER CEP has been issued for it. The manufacturer submits a Nucynta ER CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nucynta ER CEP holder for the record. Additionally, the data presented in the Nucynta ER CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nucynta ER DMF.
A Nucynta ER CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nucynta ER 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 Nucynta ER suppliers with CEP (COS) on PharmaCompass.
A Nucynta ER written confirmation (Nucynta ER WC) is an official document issued by a regulatory agency to a Nucynta ER manufacturer, verifying that the manufacturing facility of a Nucynta ER active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nucynta ER APIs or Nucynta ER finished pharmaceutical products to another nation, regulatory agencies frequently require a Nucynta ER WC (written confirmation) as part of the regulatory process.
click here to find a list of Nucynta ER 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 Nucynta ER as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nucynta ER 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 Nucynta ER 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 Nucynta ER and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nucynta ER NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nucynta ER suppliers with NDC on PharmaCompass.
Nucynta ER 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 Nucynta ER 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 Nucynta ER GMP manufacturer or Nucynta ER GMP API supplier for your needs.
A Nucynta ER CoA (Certificate of Analysis) is a formal document that attests to Nucynta ER's compliance with Nucynta ER specifications and serves as a tool for batch-level quality control.
Nucynta ER CoA mostly includes findings from lab analyses of a specific batch. For each Nucynta ER 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.
Nucynta ER may be tested according to a variety of international standards, such as European Pharmacopoeia (Nucynta ER EP), Nucynta ER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nucynta ER USP).
Comment (4)
