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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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A Phloroglucinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phloroglucinol, including repackagers and relabelers. The FDA regulates Phloroglucinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phloroglucinol 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phloroglucinol supplier is an individual or a company that provides Phloroglucinol active pharmaceutical ingredient (API) or Phloroglucinol finished formulations upon request. The Phloroglucinol suppliers may include Phloroglucinol API manufacturers, exporters, distributors and traders.
click here to find a list of Phloroglucinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phloroglucinol DMF (Drug Master File) is a document detailing the whole manufacturing process of Phloroglucinol active pharmaceutical ingredient (API) in detail. Different forms of Phloroglucinol DMFs exist exist since differing nations have different regulations, such as Phloroglucinol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phloroglucinol DMF submitted to regulatory agencies in the US is known as a USDMF. Phloroglucinol USDMF includes data on Phloroglucinol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phloroglucinol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phloroglucinol 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 Drug Master File in Korea (Phloroglucinol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Phloroglucinol. The MFDS reviews the Phloroglucinol KDMF as part of the drug registration process and uses the information provided in the Phloroglucinol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Phloroglucinol 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Phloroglucinol suppliers with KDMF on PharmaCompass.
A Phloroglucinol CEP of the European Pharmacopoeia monograph is often referred to as a Phloroglucinol Certificate of Suitability (COS). The purpose of a Phloroglucinol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Phloroglucinol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Phloroglucinol to their clients by showing that a Phloroglucinol CEP has been issued for it. The manufacturer submits a Phloroglucinol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Phloroglucinol CEP holder for the record. Additionally, the data presented in the Phloroglucinol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Phloroglucinol DMF.
A Phloroglucinol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phloroglucinol 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 suppliers with CEP (COS) on PharmaCompass.
Phloroglucinol 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 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 GMP manufacturer or Phloroglucinol GMP API supplier for your needs.
A Phloroglucinol CoA (Certificate of Analysis) is a formal document that attests to Phloroglucinol's compliance with Phloroglucinol specifications and serves as a tool for batch-level quality control.
Phloroglucinol CoA mostly includes findings from lab analyses of a specific batch. For each Phloroglucinol 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Phloroglucinol EP), Phloroglucinol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phloroglucinol USP).
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