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API SUPPLIERS
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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
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-13
Pay. Date : 2014-01-20
DMF Number : 25361
Submission : 2011-11-16
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
With Fermion, start the journey of your innovative API.
Certificate Number : R0-CEP 2021-262 - Rev 00
Status : Valid
Issue Date : 2022-10-27
Type : Chemical
Substance Number : 1711
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Busipirone Hydrochloride IP/USP/EP
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm : Plot No. 41, 42/2, 42/1/B, 43, 40, 59, 58 GIDC, Vapi, Dist: Valsad -396195, Guja...
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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...
About the Company : Unimark Remedies Ltd is a leading API manufacturer with over 18 years of excellence, now fully owned by Shamrock Pharma Group. We provide affordable generic APIs for local and glob...
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Regulatory Info :
Registration Country : Sweden
Brand Name : Anksilon
Dosage Form : TABLET
Dosage Strength : 10 MG
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Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Anksilon
Dosage Form : TABLET
Dosage Strength : 5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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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 Bespar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bespar, including repackagers and relabelers. The FDA regulates Bespar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bespar 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 Bespar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bespar supplier is an individual or a company that provides Bespar active pharmaceutical ingredient (API) or Bespar finished formulations upon request. The Bespar suppliers may include Bespar API manufacturers, exporters, distributors and traders.
click here to find a list of Bespar suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bespar DMF (Drug Master File) is a document detailing the whole manufacturing process of Bespar active pharmaceutical ingredient (API) in detail. Different forms of Bespar DMFs exist exist since differing nations have different regulations, such as Bespar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bespar DMF submitted to regulatory agencies in the US is known as a USDMF. Bespar USDMF includes data on Bespar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bespar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bespar 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 Bespar Drug Master File in Korea (Bespar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bespar. The MFDS reviews the Bespar KDMF as part of the drug registration process and uses the information provided in the Bespar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bespar 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 Bespar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bespar suppliers with KDMF on PharmaCompass.
A Bespar CEP of the European Pharmacopoeia monograph is often referred to as a Bespar Certificate of Suitability (COS). The purpose of a Bespar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bespar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bespar to their clients by showing that a Bespar CEP has been issued for it. The manufacturer submits a Bespar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bespar CEP holder for the record. Additionally, the data presented in the Bespar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bespar DMF.
A Bespar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bespar 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 Bespar suppliers with CEP (COS) on PharmaCompass.
A Bespar written confirmation (Bespar WC) is an official document issued by a regulatory agency to a Bespar manufacturer, verifying that the manufacturing facility of a Bespar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bespar APIs or Bespar finished pharmaceutical products to another nation, regulatory agencies frequently require a Bespar WC (written confirmation) as part of the regulatory process.
click here to find a list of Bespar 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 Bespar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bespar 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 Bespar 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 Bespar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bespar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bespar suppliers with NDC on PharmaCompass.
Bespar 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 Bespar 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 Bespar GMP manufacturer or Bespar GMP API supplier for your needs.
A Bespar CoA (Certificate of Analysis) is a formal document that attests to Bespar's compliance with Bespar specifications and serves as a tool for batch-level quality control.
Bespar CoA mostly includes findings from lab analyses of a specific batch. For each Bespar 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.
Bespar may be tested according to a variety of international standards, such as European Pharmacopoeia (Bespar EP), Bespar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bespar USP).
