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