Synopsis
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USDMF
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CEP/COS
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EU WC
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NDC API
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VMF
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FDF
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Europe
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
US Medicaid
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Annual Reports
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Finished Drug Prices
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API SUPPLIERS
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KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Cefotiam Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefotiam Hydrochloride, including repackagers and relabelers. The FDA regulates Cefotiam Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefotiam Hydrochloride 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 Cefotiam Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefotiam Hydrochloride supplier is an individual or a company that provides Cefotiam Hydrochloride active pharmaceutical ingredient (API) or Cefotiam Hydrochloride finished formulations upon request. The Cefotiam Hydrochloride suppliers may include Cefotiam Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cefotiam Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Cefotiam Hydrochloride Drug Master File in Japan (Cefotiam Hydrochloride JDMF) empowers Cefotiam Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Cefotiam Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Cefotiam Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Cefotiam Hydrochloride suppliers with JDMF 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 Cefotiam Hydrochloride Drug Master File in Korea (Cefotiam Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefotiam Hydrochloride. The MFDS reviews the Cefotiam Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Cefotiam Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefotiam Hydrochloride 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 Cefotiam Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefotiam Hydrochloride suppliers with KDMF on PharmaCompass.
Cefotiam Hydrochloride 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 Cefotiam Hydrochloride 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 Cefotiam Hydrochloride GMP manufacturer or Cefotiam Hydrochloride GMP API supplier for your needs.
A Cefotiam Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Cefotiam Hydrochloride's compliance with Cefotiam Hydrochloride specifications and serves as a tool for batch-level quality control.
Cefotiam Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cefotiam Hydrochloride 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.
Cefotiam Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefotiam Hydrochloride EP), Cefotiam Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefotiam Hydrochloride USP).
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