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API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
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USDMF
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40509
Submission : 2024-09-24
Status :
Type : II
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
About the Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities ar...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Phloroglucinol 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 Phloroglucinol manufacturer or Phloroglucinol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phloroglucinol manufacturer or Phloroglucinol supplier.
PharmaCompass also assists you with knowing the Phloroglucinol API Price utilized in the formulation of products. Phloroglucinol API Price is not always fixed or binding as the Phloroglucinol Price is obtained through a variety of data sources. The Phloroglucinol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Phloroglucinol Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phloroglucinol Dihydrate, including repackagers and relabelers. The FDA regulates Phloroglucinol Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phloroglucinol Dihydrate 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 Phloroglucinol Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phloroglucinol Dihydrate supplier is an individual or a company that provides Phloroglucinol Dihydrate active pharmaceutical ingredient (API) or Phloroglucinol Dihydrate finished formulations upon request. The Phloroglucinol Dihydrate suppliers may include Phloroglucinol Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Phloroglucinol Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phloroglucinol Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Phloroglucinol Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Phloroglucinol Dihydrate DMFs exist exist since differing nations have different regulations, such as Phloroglucinol Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phloroglucinol Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Phloroglucinol Dihydrate USDMF includes data on Phloroglucinol Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phloroglucinol Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phloroglucinol Dihydrate 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 Phloroglucinol Dihydrate Drug Master File in Korea (Phloroglucinol Dihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Phloroglucinol Dihydrate. The MFDS reviews the Phloroglucinol Dihydrate KDMF as part of the drug registration process and uses the information provided in the Phloroglucinol Dihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Phloroglucinol Dihydrate 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 Phloroglucinol Dihydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Phloroglucinol Dihydrate suppliers with KDMF on PharmaCompass.
A Phloroglucinol Dihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Phloroglucinol Dihydrate Certificate of Suitability (COS). The purpose of a Phloroglucinol Dihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Phloroglucinol Dihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Phloroglucinol Dihydrate to their clients by showing that a Phloroglucinol Dihydrate CEP has been issued for it. The manufacturer submits a Phloroglucinol Dihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Phloroglucinol Dihydrate CEP holder for the record. Additionally, the data presented in the Phloroglucinol Dihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Phloroglucinol Dihydrate DMF.
A Phloroglucinol Dihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phloroglucinol Dihydrate 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 Phloroglucinol Dihydrate suppliers with CEP (COS) on PharmaCompass.
Phloroglucinol Dihydrate 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 Phloroglucinol Dihydrate 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 Phloroglucinol Dihydrate GMP manufacturer or Phloroglucinol Dihydrate GMP API supplier for your needs.
A Phloroglucinol Dihydrate CoA (Certificate of Analysis) is a formal document that attests to Phloroglucinol Dihydrate's compliance with Phloroglucinol Dihydrate specifications and serves as a tool for batch-level quality control.
Phloroglucinol Dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Phloroglucinol Dihydrate 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.
Phloroglucinol Dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Phloroglucinol Dihydrate EP), Phloroglucinol Dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phloroglucinol Dihydrate USP).
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