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API SUPPLIERS
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USDMF
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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
Related Excipient Companies
Faran Shimi Pharmaceutical
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ABOUT THIS PAGE
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PharmaCompass offers a list of Bupropion Hydrobromide 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 Bupropion Hydrobromide manufacturer or Bupropion Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bupropion Hydrobromide manufacturer or Bupropion Hydrobromide supplier.
PharmaCompass also assists you with knowing the Bupropion Hydrobromide API Price utilized in the formulation of products. Bupropion Hydrobromide API Price is not always fixed or binding as the Bupropion Hydrobromide Price is obtained through a variety of data sources. The Bupropion Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aplenzin ER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aplenzin ER, including repackagers and relabelers. The FDA regulates Aplenzin ER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aplenzin ER 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 Aplenzin ER manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aplenzin ER supplier is an individual or a company that provides Aplenzin ER active pharmaceutical ingredient (API) or Aplenzin ER finished formulations upon request. The Aplenzin ER suppliers may include Aplenzin ER API manufacturers, exporters, distributors and traders.
click here to find a list of Aplenzin ER suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aplenzin ER DMF (Drug Master File) is a document detailing the whole manufacturing process of Aplenzin ER active pharmaceutical ingredient (API) in detail. Different forms of Aplenzin ER DMFs exist exist since differing nations have different regulations, such as Aplenzin ER USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aplenzin ER DMF submitted to regulatory agencies in the US is known as a USDMF. Aplenzin ER USDMF includes data on Aplenzin ER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aplenzin ER USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aplenzin ER suppliers with USDMF 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 Aplenzin ER as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aplenzin ER 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 Aplenzin ER 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 Aplenzin ER and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aplenzin ER NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aplenzin ER suppliers with NDC on PharmaCompass.
Aplenzin ER 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 Aplenzin ER 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 Aplenzin ER GMP manufacturer or Aplenzin ER GMP API supplier for your needs.
A Aplenzin ER CoA (Certificate of Analysis) is a formal document that attests to Aplenzin ER's compliance with Aplenzin ER specifications and serves as a tool for batch-level quality control.
Aplenzin ER CoA mostly includes findings from lab analyses of a specific batch. For each Aplenzin ER 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.
Aplenzin ER may be tested according to a variety of international standards, such as European Pharmacopoeia (Aplenzin ER EP), Aplenzin ER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aplenzin ER USP).
