Synopsis
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
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
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
Controlled & Modified Release
Thickeners and Stabilizers
Granulation
Disintegrants & Superdisintegrants
Direct Compression
Solubilizers
Lubricants & Glidants
Topical
Film Formers & Plasticizers
Co-Processed Excipients
Taste Masking
Parenteral
Empty Capsules
Coloring Agents
Rheology Modifiers
Vegetarian Capsules
API Stability Enhancers
Chewable & Orodispersible Aids
Emulsifying Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
ABOUT THIS PAGE
66
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).
