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DOSAGE - TABLET;ORAL - 25MG **Federal Registe...DOSAGE - TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 11722
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 75MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12546
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ABOUT THIS PAGE
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PharmaCompass offers a list of Diethylpropion 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 Diethylpropion Hydrochloride manufacturer or Diethylpropion Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Diethylpropion Hydrochloride manufacturer or Diethylpropion Hydrochloride supplier.
PharmaCompass also assists you with knowing the Diethylpropion Hydrochloride API Price utilized in the formulation of products. Diethylpropion Hydrochloride API Price is not always fixed or binding as the Diethylpropion Hydrochloride Price is obtained through a variety of data sources. The Diethylpropion Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Diethylpropion Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diethylpropion Hydrochloride, including repackagers and relabelers. The FDA regulates Diethylpropion Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diethylpropion 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 Diethylpropion Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diethylpropion Hydrochloride supplier is an individual or a company that provides Diethylpropion Hydrochloride active pharmaceutical ingredient (API) or Diethylpropion Hydrochloride finished formulations upon request. The Diethylpropion Hydrochloride suppliers may include Diethylpropion Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Diethylpropion Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diethylpropion Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Diethylpropion Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Diethylpropion Hydrochloride DMFs exist exist since differing nations have different regulations, such as Diethylpropion Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diethylpropion Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Diethylpropion Hydrochloride USDMF includes data on Diethylpropion Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diethylpropion Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diethylpropion Hydrochloride suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Diethylpropion Hydrochloride Drug Master File in Korea (Diethylpropion Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Diethylpropion Hydrochloride. The MFDS reviews the Diethylpropion Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Diethylpropion Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Diethylpropion Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Diethylpropion Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Diethylpropion Hydrochloride suppliers with KDMF 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 Diethylpropion Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Diethylpropion 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 Diethylpropion 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 Diethylpropion Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Diethylpropion Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Diethylpropion Hydrochloride suppliers with NDC on PharmaCompass.
Diethylpropion 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 Diethylpropion 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 Diethylpropion Hydrochloride GMP manufacturer or Diethylpropion Hydrochloride GMP API supplier for your needs.
A Diethylpropion Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Diethylpropion Hydrochloride's compliance with Diethylpropion Hydrochloride specifications and serves as a tool for batch-level quality control.
Diethylpropion Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Diethylpropion 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.
Diethylpropion Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Diethylpropion Hydrochloride EP), Diethylpropion Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Diethylpropion Hydrochloride USP).
