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API SUPPLIERS
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USDMF
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FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 100MG/ML
USFDA APPLICATION NUMBER - 21171
DOSAGE - INJECTABLE;INJECTION - 25MG/ML
USFDA APPLICATION NUMBER - 21171
DOSAGE - INJECTABLE;INJECTION - 50MG/ML
USFDA APPLICATION NUMBER - 21171
DOSAGE - INJECTABLE;INJECTION - 75MG/ML
USFDA APPLICATION NUMBER - 21171
DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 5010
DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 5010
DOSAGE - INJECTABLE;INJECTION - 10MG/ML
USFDA APPLICATION NUMBER - 88432
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Meperidine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meperidine Hydrochloride, including repackagers and relabelers. The FDA regulates Meperidine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meperidine 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 Meperidine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Meperidine Hydrochloride supplier is an individual or a company that provides Meperidine Hydrochloride active pharmaceutical ingredient (API) or Meperidine Hydrochloride finished formulations upon request. The Meperidine Hydrochloride suppliers may include Meperidine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Meperidine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Meperidine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Meperidine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Meperidine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Meperidine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Meperidine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Meperidine Hydrochloride USDMF includes data on Meperidine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Meperidine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Meperidine 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 Meperidine Hydrochloride Drug Master File in Japan (Meperidine Hydrochloride JDMF) empowers Meperidine 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 Meperidine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Meperidine 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 Meperidine Hydrochloride suppliers with JDMF on PharmaCompass.
A Meperidine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Meperidine Hydrochloride Certificate of Suitability (COS). The purpose of a Meperidine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Meperidine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Meperidine Hydrochloride to their clients by showing that a Meperidine Hydrochloride CEP has been issued for it. The manufacturer submits a Meperidine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Meperidine Hydrochloride CEP holder for the record. Additionally, the data presented in the Meperidine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Meperidine Hydrochloride DMF.
A Meperidine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Meperidine Hydrochloride 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 Meperidine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Meperidine Hydrochloride written confirmation (Meperidine Hydrochloride WC) is an official document issued by a regulatory agency to a Meperidine Hydrochloride manufacturer, verifying that the manufacturing facility of a Meperidine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Meperidine Hydrochloride APIs or Meperidine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Meperidine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Meperidine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Meperidine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Meperidine Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Meperidine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Meperidine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Meperidine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Meperidine Hydrochloride suppliers with NDC on PharmaCompass.
Meperidine 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 Meperidine 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 Meperidine Hydrochloride GMP manufacturer or Meperidine Hydrochloride GMP API supplier for your needs.
A Meperidine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Meperidine Hydrochloride's compliance with Meperidine Hydrochloride specifications and serves as a tool for batch-level quality control.
Meperidine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Meperidine 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.
Meperidine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Meperidine Hydrochloride EP), Meperidine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Meperidine Hydrochloride USP).
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