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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Others
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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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With Virupaksha, you get a quality product with on-time delivery.
Certificate Number : CEP 2023-142 - Rev 00
Status : Valid
Issue Date : 2024-10-31
Type : Chemical
Substance Number : 3035
AMI Lifesciences is Driven by Chemistry. Powered by People.
Certificate Number : R0-CEP 2021-290 - Rev 00
Status : Valid
Issue Date : 2022-11-24
Type : Chemical
Substance Number : 3035
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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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**Fe...DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Nucynta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nucynta, including repackagers and relabelers. The FDA regulates Nucynta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nucynta 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nucynta supplier is an individual or a company that provides Nucynta active pharmaceutical ingredient (API) or Nucynta finished formulations upon request. The Nucynta suppliers may include Nucynta API manufacturers, exporters, distributors and traders.
click here to find a list of Nucynta suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nucynta DMF (Drug Master File) is a document detailing the whole manufacturing process of Nucynta active pharmaceutical ingredient (API) in detail. Different forms of Nucynta DMFs exist exist since differing nations have different regulations, such as Nucynta USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nucynta DMF submitted to regulatory agencies in the US is known as a USDMF. Nucynta USDMF includes data on Nucynta's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nucynta USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nucynta 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 Drug Master File in Korea (Nucynta KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nucynta. The MFDS reviews the Nucynta KDMF as part of the drug registration process and uses the information provided in the Nucynta KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nucynta 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nucynta suppliers with KDMF on PharmaCompass.
A Nucynta CEP of the European Pharmacopoeia monograph is often referred to as a Nucynta Certificate of Suitability (COS). The purpose of a Nucynta CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nucynta EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nucynta to their clients by showing that a Nucynta CEP has been issued for it. The manufacturer submits a Nucynta CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nucynta CEP holder for the record. Additionally, the data presented in the Nucynta CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nucynta DMF.
A Nucynta CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nucynta 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 suppliers with CEP (COS) on PharmaCompass.
A Nucynta written confirmation (Nucynta WC) is an official document issued by a regulatory agency to a Nucynta manufacturer, verifying that the manufacturing facility of a Nucynta active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nucynta APIs or Nucynta finished pharmaceutical products to another nation, regulatory agencies frequently require a Nucynta WC (written confirmation) as part of the regulatory process.
click here to find a list of Nucynta 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nucynta 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nucynta NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nucynta suppliers with NDC on PharmaCompass.
Nucynta 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 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 GMP manufacturer or Nucynta GMP API supplier for your needs.
A Nucynta CoA (Certificate of Analysis) is a formal document that attests to Nucynta's compliance with Nucynta specifications and serves as a tool for batch-level quality control.
Nucynta CoA mostly includes findings from lab analyses of a specific batch. For each Nucynta 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Nucynta EP), Nucynta JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nucynta USP).
