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ABOUT THIS PAGE
A Thiaproline-M-Amino Benzoic Acid Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thiaproline-M-Amino Benzoic Acid Hydrochloride, including repackagers and relabelers. The FDA regulates Thiaproline-M-Amino Benzoic Acid Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thiaproline-M-Amino Benzoic Acid 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.
A Thiaproline-M-Amino Benzoic Acid Hydrochloride supplier is an individual or a company that provides Thiaproline-M-Amino Benzoic Acid Hydrochloride active pharmaceutical ingredient (API) or Thiaproline-M-Amino Benzoic Acid Hydrochloride finished formulations upon request. The Thiaproline-M-Amino Benzoic Acid Hydrochloride suppliers may include Thiaproline-M-Amino Benzoic Acid Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Thiaproline-M-Amino Benzoic Acid Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thiaproline-M-Amino Benzoic Acid Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Thiaproline-M-Amino Benzoic Acid Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Thiaproline-M-Amino Benzoic Acid Hydrochloride DMFs exist exist since differing nations have different regulations, such as Thiaproline-M-Amino Benzoic Acid Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thiaproline-M-Amino Benzoic Acid Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Thiaproline-M-Amino Benzoic Acid Hydrochloride USDMF includes data on Thiaproline-M-Amino Benzoic Acid Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thiaproline-M-Amino Benzoic Acid Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thiaproline-M-Amino Benzoic Acid Hydrochloride suppliers with USDMF 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 Thiaproline-M-Amino Benzoic Acid Hydrochloride Drug Master File in Japan (Thiaproline-M-Amino Benzoic Acid Hydrochloride JDMF) empowers Thiaproline-M-Amino Benzoic Acid 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 Thiaproline-M-Amino Benzoic Acid Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Thiaproline-M-Amino Benzoic Acid 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 Thiaproline-M-Amino Benzoic Acid Hydrochloride suppliers with JDMF on PharmaCompass.
Thiaproline-M-Amino Benzoic Acid 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 Thiaproline-M-Amino Benzoic Acid 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 Thiaproline-M-Amino Benzoic Acid Hydrochloride GMP manufacturer or Thiaproline-M-Amino Benzoic Acid Hydrochloride GMP API supplier for your needs.
A Thiaproline-M-Amino Benzoic Acid Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Thiaproline-M-Amino Benzoic Acid Hydrochloride's compliance with Thiaproline-M-Amino Benzoic Acid Hydrochloride specifications and serves as a tool for batch-level quality control.
Thiaproline-M-Amino Benzoic Acid Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Thiaproline-M-Amino Benzoic Acid 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.
Thiaproline-M-Amino Benzoic Acid Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Thiaproline-M-Amino Benzoic Acid Hydrochloride EP), Thiaproline-M-Amino Benzoic Acid Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Thiaproline-M-Amino Benzoic Acid Hydrochloride USP).
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