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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-19
Pay. Date : 2013-09-25
DMF Number : 27284
Submission : 2013-07-16
Status :
Type : II
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SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
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PharmaCompass offers a list of Frovatriptan Succinate Hydrate 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 Frovatriptan Succinate Hydrate manufacturer or Frovatriptan Succinate Hydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Frovatriptan Succinate Hydrate manufacturer or Frovatriptan Succinate Hydrate supplier.
PharmaCompass also assists you with knowing the Frovatriptan Succinate Hydrate API Price utilized in the formulation of products. Frovatriptan Succinate Hydrate API Price is not always fixed or binding as the Frovatriptan Succinate Hydrate Price is obtained through a variety of data sources. The Frovatriptan Succinate Hydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DSSTox_CID_28982 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_28982, including repackagers and relabelers. The FDA regulates DSSTox_CID_28982 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_28982 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 DSSTox_CID_28982 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DSSTox_CID_28982 supplier is an individual or a company that provides DSSTox_CID_28982 active pharmaceutical ingredient (API) or DSSTox_CID_28982 finished formulations upon request. The DSSTox_CID_28982 suppliers may include DSSTox_CID_28982 API manufacturers, exporters, distributors and traders.
click here to find a list of DSSTox_CID_28982 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DSSTox_CID_28982 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_28982 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_28982 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_28982 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSSTox_CID_28982 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_28982 USDMF includes data on DSSTox_CID_28982's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_28982 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DSSTox_CID_28982 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 DSSTox_CID_28982 Drug Master File in Korea (DSSTox_CID_28982 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DSSTox_CID_28982. The MFDS reviews the DSSTox_CID_28982 KDMF as part of the drug registration process and uses the information provided in the DSSTox_CID_28982 KDMF to evaluate the safety and efficacy of the drug.
After submitting a DSSTox_CID_28982 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 DSSTox_CID_28982 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DSSTox_CID_28982 suppliers with KDMF on PharmaCompass.
A DSSTox_CID_28982 written confirmation (DSSTox_CID_28982 WC) is an official document issued by a regulatory agency to a DSSTox_CID_28982 manufacturer, verifying that the manufacturing facility of a DSSTox_CID_28982 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DSSTox_CID_28982 APIs or DSSTox_CID_28982 finished pharmaceutical products to another nation, regulatory agencies frequently require a DSSTox_CID_28982 WC (written confirmation) as part of the regulatory process.
click here to find a list of DSSTox_CID_28982 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 DSSTox_CID_28982 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DSSTox_CID_28982 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 DSSTox_CID_28982 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 DSSTox_CID_28982 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DSSTox_CID_28982 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DSSTox_CID_28982 suppliers with NDC on PharmaCompass.
DSSTox_CID_28982 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 DSSTox_CID_28982 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 DSSTox_CID_28982 GMP manufacturer or DSSTox_CID_28982 GMP API supplier for your needs.
A DSSTox_CID_28982 CoA (Certificate of Analysis) is a formal document that attests to DSSTox_CID_28982's compliance with DSSTox_CID_28982 specifications and serves as a tool for batch-level quality control.
DSSTox_CID_28982 CoA mostly includes findings from lab analyses of a specific batch. For each DSSTox_CID_28982 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.
DSSTox_CID_28982 may be tested according to a variety of international standards, such as European Pharmacopoeia (DSSTox_CID_28982 EP), DSSTox_CID_28982 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSSTox_CID_28982 USP).
