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Aspen API. More than just an API.
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Registration Country : Sweden
Brand Name : Trandate
Dosage Form : TABLET
Dosage Strength : 100 MG
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Registration Country : Sweden
Aspen API. More than just an API.
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Brand Name : Trandate
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Dosage Strength : 5 MG / ML
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Registration Country : Sweden
Aspen API. More than just an API.
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Registration Country : Sweden
Brand Name : Trandate
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Dosage Strength : 200 MG
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Aspen API. More than just an API.
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Registration Country : Norway
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Registration Country : Norway
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Norway
Brand Name : The Tran Date
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 200 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Norway
Brand Name : The Tran Date
Dosage Form : Injection fluid, resolution
Dosage Strength : 5 mg/ml
Packaging : Ampoule
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Registration Country : Norway
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Registration Country : Switzerland
Brand Name : Trandate
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Dosage Strength : 100mg
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Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Trandate
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Registration Country : Switzerland
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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**Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Regist...DOSAGE - TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
A Labetalol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Labetalol Hydrochloride, including repackagers and relabelers. The FDA regulates Labetalol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Labetalol Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Labetalol Hydrochloride supplier is an individual or a company that provides Labetalol Hydrochloride active pharmaceutical ingredient (API) or Labetalol Hydrochloride finished formulations upon request. The Labetalol Hydrochloride suppliers may include Labetalol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Labetalol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Labetalol Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Labetalol Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Labetalol Hydrochloride DMFs exist exist since differing nations have different regulations, such as Labetalol Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Labetalol Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Labetalol Hydrochloride USDMF includes data on Labetalol Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Labetalol Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Labetalol Hydrochloride 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 Hydrochloride Drug Master File in Japan (Labetalol Hydrochloride JDMF) empowers Labetalol Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Labetalol Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
A Labetalol Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Labetalol Hydrochloride Certificate of Suitability (COS). The purpose of a Labetalol Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Labetalol Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Labetalol Hydrochloride to their clients by showing that a Labetalol Hydrochloride CEP has been issued for it. The manufacturer submits a Labetalol Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Labetalol Hydrochloride CEP holder for the record. Additionally, the data presented in the Labetalol Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Labetalol Hydrochloride DMF.
A Labetalol Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Labetalol Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Labetalol Hydrochloride written confirmation (Labetalol Hydrochloride WC) is an official document issued by a regulatory agency to a Labetalol Hydrochloride manufacturer, verifying that the manufacturing facility of a Labetalol Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Labetalol Hydrochloride APIs or Labetalol Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Labetalol Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Labetalol Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Labetalol Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Labetalol Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Labetalol Hydrochloride suppliers with NDC on PharmaCompass.
Labetalol Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Labetalol Hydrochloride GMP API supplier for your needs.
A Labetalol Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Labetalol Hydrochloride's compliance with Labetalol Hydrochloride specifications and serves as a tool for batch-level quality control.
Labetalol Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Labetalol Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Labetalol Hydrochloride EP), Labetalol Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Labetalol Hydrochloride USP).
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