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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18716
DOSAGE - TABLET;ORAL - 200MG **Federal Regist...DOSAGE - TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18716
DOSAGE - TABLET;ORAL - 300MG **Federal Regist...DOSAGE - TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18716
DOSAGE - TABLET;ORAL - 400MG **Federal Regist...DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18716
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ABOUT THIS PAGE
64
PharmaCompass offers a list of Labetalol Hydrochloride 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 Labetalol Hydrochloride manufacturer or Labetalol Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Labetalol Hydrochloride manufacturer or Labetalol Hydrochloride supplier.
PharmaCompass also assists you with knowing the Labetalol Hydrochloride API Price utilized in the formulation of products. Labetalol Hydrochloride API Price is not always fixed or binding as the Labetalol Hydrochloride Price is obtained through a variety of data sources. The Labetalol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Labetalol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Labetalol, including repackagers and relabelers. The FDA regulates Labetalol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Labetalol 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 Labetalol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Labetalol supplier is an individual or a company that provides Labetalol active pharmaceutical ingredient (API) or Labetalol finished formulations upon request. The Labetalol suppliers may include Labetalol API manufacturers, exporters, distributors and traders.
click here to find a list of Labetalol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Labetalol DMF (Drug Master File) is a document detailing the whole manufacturing process of Labetalol active pharmaceutical ingredient (API) in detail. Different forms of Labetalol DMFs exist exist since differing nations have different regulations, such as Labetalol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Labetalol DMF submitted to regulatory agencies in the US is known as a USDMF. Labetalol USDMF includes data on Labetalol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Labetalol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Labetalol suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Labetalol Drug Master File in Japan (Labetalol JDMF) empowers Labetalol API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Labetalol JDMF during the approval evaluation for pharmaceutical products. At the time of Labetalol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Labetalol suppliers with JDMF on PharmaCompass.
A Labetalol CEP of the European Pharmacopoeia monograph is often referred to as a Labetalol Certificate of Suitability (COS). The purpose of a Labetalol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Labetalol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Labetalol to their clients by showing that a Labetalol CEP has been issued for it. The manufacturer submits a Labetalol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Labetalol CEP holder for the record. Additionally, the data presented in the Labetalol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Labetalol DMF.
A Labetalol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Labetalol 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 Labetalol suppliers with CEP (COS) on PharmaCompass.
A Labetalol written confirmation (Labetalol WC) is an official document issued by a regulatory agency to a Labetalol manufacturer, verifying that the manufacturing facility of a Labetalol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Labetalol APIs or Labetalol finished pharmaceutical products to another nation, regulatory agencies frequently require a Labetalol WC (written confirmation) as part of the regulatory process.
click here to find a list of Labetalol 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 Labetalol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Labetalol 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 Labetalol 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 Labetalol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Labetalol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Labetalol suppliers with NDC on PharmaCompass.
Labetalol 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 Labetalol 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 Labetalol GMP manufacturer or Labetalol GMP API supplier for your needs.
A Labetalol CoA (Certificate of Analysis) is a formal document that attests to Labetalol's compliance with Labetalol specifications and serves as a tool for batch-level quality control.
Labetalol CoA mostly includes findings from lab analyses of a specific batch. For each Labetalol 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.
Labetalol may be tested according to a variety of international standards, such as European Pharmacopoeia (Labetalol EP), Labetalol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Labetalol USP).
