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Axplora- The partner of choice for complex APIs.
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JDMF
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Axplora- The partner of choice for complex APIs.
Date of Issue : 2022-03-18
Valid Till : 2025-05-28
Written Confirmation Number : WC-0019
Address of the Firm : Plot No. 115, Ramky Pharma City, SEZ, Parawada Mandal, Visakhapatnam, Andhra Pra...
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ABOUT THIS PAGE
A Landiolol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Landiolol Hydrochloride, including repackagers and relabelers. The FDA regulates Landiolol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Landiolol 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 Landiolol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Landiolol Hydrochloride supplier is an individual or a company that provides Landiolol Hydrochloride active pharmaceutical ingredient (API) or Landiolol Hydrochloride finished formulations upon request. The Landiolol Hydrochloride suppliers may include Landiolol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Landiolol 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 Landiolol Hydrochloride Drug Master File in Japan (Landiolol Hydrochloride JDMF) empowers Landiolol 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 Landiolol Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Landiolol 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 Landiolol Hydrochloride suppliers with JDMF on PharmaCompass.
A Landiolol Hydrochloride written confirmation (Landiolol Hydrochloride WC) is an official document issued by a regulatory agency to a Landiolol Hydrochloride manufacturer, verifying that the manufacturing facility of a Landiolol Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Landiolol Hydrochloride APIs or Landiolol Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Landiolol Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Landiolol Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
Landiolol 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 Landiolol 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 Landiolol Hydrochloride GMP manufacturer or Landiolol Hydrochloride GMP API supplier for your needs.
A Landiolol Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Landiolol Hydrochloride's compliance with Landiolol Hydrochloride specifications and serves as a tool for batch-level quality control.
Landiolol Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Landiolol 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.
Landiolol Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Landiolol Hydrochloride EP), Landiolol Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Landiolol Hydrochloride USP).
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