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PharmaCompass offers a list of Theobromine 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 Theobromine manufacturer or Theobromine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Theobromine manufacturer or Theobromine supplier.
PharmaCompass also assists you with knowing the Theobromine API Price utilized in the formulation of products. Theobromine API Price is not always fixed or binding as the Theobromine Price is obtained through a variety of data sources. The Theobromine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Theobromine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Theobromine, including repackagers and relabelers. The FDA regulates Theobromine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Theobromine 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 Theobromine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Theobromine supplier is an individual or a company that provides Theobromine active pharmaceutical ingredient (API) or Theobromine finished formulations upon request. The Theobromine suppliers may include Theobromine API manufacturers, exporters, distributors and traders.
click here to find a list of Theobromine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Theobromine Drug Master File in Korea (Theobromine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Theobromine. The MFDS reviews the Theobromine KDMF as part of the drug registration process and uses the information provided in the Theobromine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Theobromine 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 Theobromine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Theobromine suppliers with KDMF on PharmaCompass.
A Theobromine CEP of the European Pharmacopoeia monograph is often referred to as a Theobromine Certificate of Suitability (COS). The purpose of a Theobromine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Theobromine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Theobromine to their clients by showing that a Theobromine CEP has been issued for it. The manufacturer submits a Theobromine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Theobromine CEP holder for the record. Additionally, the data presented in the Theobromine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Theobromine DMF.
A Theobromine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Theobromine 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 Theobromine suppliers with CEP (COS) on PharmaCompass.
A Theobromine written confirmation (Theobromine WC) is an official document issued by a regulatory agency to a Theobromine manufacturer, verifying that the manufacturing facility of a Theobromine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Theobromine APIs or Theobromine finished pharmaceutical products to another nation, regulatory agencies frequently require a Theobromine WC (written confirmation) as part of the regulatory process.
click here to find a list of Theobromine suppliers with Written Confirmation (WC) on PharmaCompass.
Theobromine 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 Theobromine 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 Theobromine GMP manufacturer or Theobromine GMP API supplier for your needs.
A Theobromine CoA (Certificate of Analysis) is a formal document that attests to Theobromine's compliance with Theobromine specifications and serves as a tool for batch-level quality control.
Theobromine CoA mostly includes findings from lab analyses of a specific batch. For each Theobromine 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.
Theobromine may be tested according to a variety of international standards, such as European Pharmacopoeia (Theobromine EP), Theobromine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Theobromine USP).
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