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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 174M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 174MG
USFDA APPLICATION NUMBER - 22108
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 348M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 348MG
USFDA APPLICATION NUMBER - 22108
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 522M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 522MG
USFDA APPLICATION NUMBER - 22108
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ABOUT THIS PAGE
A Bupropion Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bupropion Hydrobromide, including repackagers and relabelers. The FDA regulates Bupropion Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bupropion Hydrobromide 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 Bupropion Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bupropion Hydrobromide supplier is an individual or a company that provides Bupropion Hydrobromide active pharmaceutical ingredient (API) or Bupropion Hydrobromide finished formulations upon request. The Bupropion Hydrobromide suppliers may include Bupropion Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Bupropion Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bupropion Hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Bupropion Hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of Bupropion Hydrobromide DMFs exist exist since differing nations have different regulations, such as Bupropion Hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bupropion Hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. Bupropion Hydrobromide USDMF includes data on Bupropion Hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bupropion Hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bupropion Hydrobromide suppliers with USDMF on PharmaCompass.
A Bupropion Hydrobromide written confirmation (Bupropion Hydrobromide WC) is an official document issued by a regulatory agency to a Bupropion Hydrobromide manufacturer, verifying that the manufacturing facility of a Bupropion Hydrobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bupropion Hydrobromide APIs or Bupropion Hydrobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Bupropion Hydrobromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Bupropion Hydrobromide 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 Bupropion Hydrobromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bupropion Hydrobromide 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 Bupropion Hydrobromide 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 Bupropion Hydrobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bupropion Hydrobromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bupropion Hydrobromide suppliers with NDC on PharmaCompass.
Bupropion Hydrobromide 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 Bupropion Hydrobromide 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 Bupropion Hydrobromide GMP manufacturer or Bupropion Hydrobromide GMP API supplier for your needs.
A Bupropion Hydrobromide CoA (Certificate of Analysis) is a formal document that attests to Bupropion Hydrobromide's compliance with Bupropion Hydrobromide specifications and serves as a tool for batch-level quality control.
Bupropion Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Bupropion Hydrobromide 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.
Bupropion Hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Bupropion Hydrobromide EP), Bupropion Hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bupropion Hydrobromide USP).
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