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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Rampex Labs – Simplifying Synthesis with Innovation, Quality, and Commitment to Global Pharmaceutical Excellence.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Together we can improve the quality of life
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USDMF
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-10-07
DMF Number : 28627
Submission : 2014-09-10
Status :
Type : II
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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
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DOSAGE - TABLET;ORAL - EQ 5MG BASE;80MG
USFDA APPLICATION NUMBER - 206302
DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 21742
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE
USFDA APPLICATION NUMBER - 21742
DOSAGE - TABLET;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21742
DOSAGE - TABLET;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 21742
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
14
PharmaCompass offers a list of Nebivolol 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 Nebivolol manufacturer or Nebivolol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nebivolol manufacturer or Nebivolol supplier.
A Narbivolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Narbivolol, including repackagers and relabelers. The FDA regulates Narbivolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Narbivolol 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 Narbivolol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Narbivolol supplier is an individual or a company that provides Narbivolol active pharmaceutical ingredient (API) or Narbivolol finished formulations upon request. The Narbivolol suppliers may include Narbivolol API manufacturers, exporters, distributors and traders.
click here to find a list of Narbivolol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Narbivolol DMF (Drug Master File) is a document detailing the whole manufacturing process of Narbivolol active pharmaceutical ingredient (API) in detail. Different forms of Narbivolol DMFs exist exist since differing nations have different regulations, such as Narbivolol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Narbivolol DMF submitted to regulatory agencies in the US is known as a USDMF. Narbivolol USDMF includes data on Narbivolol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Narbivolol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Narbivolol 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 Narbivolol Drug Master File in Korea (Narbivolol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Narbivolol. The MFDS reviews the Narbivolol KDMF as part of the drug registration process and uses the information provided in the Narbivolol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Narbivolol 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 Narbivolol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Narbivolol suppliers with KDMF on PharmaCompass.
A Narbivolol CEP of the European Pharmacopoeia monograph is often referred to as a Narbivolol Certificate of Suitability (COS). The purpose of a Narbivolol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Narbivolol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Narbivolol to their clients by showing that a Narbivolol CEP has been issued for it. The manufacturer submits a Narbivolol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Narbivolol CEP holder for the record. Additionally, the data presented in the Narbivolol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Narbivolol DMF.
A Narbivolol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Narbivolol 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 Narbivolol suppliers with CEP (COS) on PharmaCompass.
A Narbivolol written confirmation (Narbivolol WC) is an official document issued by a regulatory agency to a Narbivolol manufacturer, verifying that the manufacturing facility of a Narbivolol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Narbivolol APIs or Narbivolol finished pharmaceutical products to another nation, regulatory agencies frequently require a Narbivolol WC (written confirmation) as part of the regulatory process.
click here to find a list of Narbivolol 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 Narbivolol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Narbivolol 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 Narbivolol 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 Narbivolol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Narbivolol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Narbivolol suppliers with NDC on PharmaCompass.
Narbivolol 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 Narbivolol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Narbivolol GMP manufacturer or Narbivolol GMP API supplier for your needs.
A Narbivolol CoA (Certificate of Analysis) is a formal document that attests to Narbivolol's compliance with Narbivolol specifications and serves as a tool for batch-level quality control.
Narbivolol CoA mostly includes findings from lab analyses of a specific batch. For each Narbivolol 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.
Narbivolol may be tested according to a variety of international standards, such as European Pharmacopoeia (Narbivolol EP), Narbivolol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Narbivolol USP).
