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USDMF
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-07-21
DMF Number : 11148
Submission : 1994-10-21
Status :
Type : II
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With Fermion, start the journey of your innovative API.
About the Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & F...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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PharmaCompass offers a list of Buspirone 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 Buspirone Hydrochloride manufacturer or Buspirone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Buspirone Hydrochloride manufacturer or Buspirone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Buspirone Hydrochloride API Price utilized in the formulation of products. Buspirone Hydrochloride API Price is not always fixed or binding as the Buspirone Hydrochloride Price is obtained through a variety of data sources. The Buspirone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Buspirone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buspirone Hydrochloride, including repackagers and relabelers. The FDA regulates Buspirone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buspirone 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 Buspirone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Buspirone Hydrochloride supplier is an individual or a company that provides Buspirone Hydrochloride active pharmaceutical ingredient (API) or Buspirone Hydrochloride finished formulations upon request. The Buspirone Hydrochloride suppliers may include Buspirone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Buspirone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Buspirone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Buspirone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Buspirone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Buspirone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Buspirone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Buspirone Hydrochloride USDMF includes data on Buspirone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Buspirone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Buspirone 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 Buspirone Hydrochloride Drug Master File in Korea (Buspirone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Buspirone Hydrochloride. The MFDS reviews the Buspirone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Buspirone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Buspirone 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 Buspirone Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Buspirone Hydrochloride suppliers with KDMF on PharmaCompass.
A Buspirone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Buspirone Hydrochloride Certificate of Suitability (COS). The purpose of a Buspirone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Buspirone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Buspirone Hydrochloride to their clients by showing that a Buspirone Hydrochloride CEP has been issued for it. The manufacturer submits a Buspirone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Buspirone Hydrochloride CEP holder for the record. Additionally, the data presented in the Buspirone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Buspirone Hydrochloride DMF.
A Buspirone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Buspirone 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 Buspirone Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Buspirone Hydrochloride written confirmation (Buspirone Hydrochloride WC) is an official document issued by a regulatory agency to a Buspirone Hydrochloride manufacturer, verifying that the manufacturing facility of a Buspirone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Buspirone Hydrochloride APIs or Buspirone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Buspirone Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Buspirone 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 Buspirone Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Buspirone 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 Buspirone 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 Buspirone Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Buspirone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Buspirone Hydrochloride suppliers with NDC on PharmaCompass.
Buspirone 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 Buspirone 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 Buspirone Hydrochloride GMP manufacturer or Buspirone Hydrochloride GMP API supplier for your needs.
A Buspirone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Buspirone Hydrochloride's compliance with Buspirone Hydrochloride specifications and serves as a tool for batch-level quality control.
Buspirone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Buspirone 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.
Buspirone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Buspirone Hydrochloride EP), Buspirone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Buspirone Hydrochloride USP).
