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API SUPPLIERS
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USDMF
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Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish form...
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ABOUT THIS PAGE
A Imidapril Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imidapril Hydrochloride, including repackagers and relabelers. The FDA regulates Imidapril Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imidapril 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 Imidapril Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Imidapril Hydrochloride supplier is an individual or a company that provides Imidapril Hydrochloride active pharmaceutical ingredient (API) or Imidapril Hydrochloride finished formulations upon request. The Imidapril Hydrochloride suppliers may include Imidapril Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Imidapril Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Imidapril Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Imidapril Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Imidapril Hydrochloride DMFs exist exist since differing nations have different regulations, such as Imidapril Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imidapril Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Imidapril Hydrochloride USDMF includes data on Imidapril Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imidapril Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Imidapril 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 Imidapril Hydrochloride Drug Master File in Japan (Imidapril Hydrochloride JDMF) empowers Imidapril 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 Imidapril Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Imidapril 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 Imidapril Hydrochloride suppliers with JDMF on PharmaCompass.
A Imidapril Hydrochloride written confirmation (Imidapril Hydrochloride WC) is an official document issued by a regulatory agency to a Imidapril Hydrochloride manufacturer, verifying that the manufacturing facility of a Imidapril Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Imidapril Hydrochloride APIs or Imidapril Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Imidapril Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Imidapril Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
Imidapril 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 Imidapril 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 Imidapril Hydrochloride GMP manufacturer or Imidapril Hydrochloride GMP API supplier for your needs.
A Imidapril Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Imidapril Hydrochloride's compliance with Imidapril Hydrochloride specifications and serves as a tool for batch-level quality control.
Imidapril Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Imidapril 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.
Imidapril Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Imidapril Hydrochloride EP), Imidapril Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Imidapril Hydrochloride USP).
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