Synopsis
0
CEP/COS
0
EU WC
0
KDMF
0
VMF
0
API
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
API SUPPLIERS
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
ABOUT THIS PAGE
A Pirenzepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pirenzepine, including repackagers and relabelers. The FDA regulates Pirenzepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pirenzepine 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 Pirenzepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pirenzepine supplier is an individual or a company that provides Pirenzepine active pharmaceutical ingredient (API) or Pirenzepine finished formulations upon request. The Pirenzepine suppliers may include Pirenzepine API manufacturers, exporters, distributors and traders.
click here to find a list of Pirenzepine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pirenzepine DMF (Drug Master File) is a document detailing the whole manufacturing process of Pirenzepine active pharmaceutical ingredient (API) in detail. Different forms of Pirenzepine DMFs exist exist since differing nations have different regulations, such as Pirenzepine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pirenzepine DMF submitted to regulatory agencies in the US is known as a USDMF. Pirenzepine USDMF includes data on Pirenzepine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pirenzepine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pirenzepine 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 Pirenzepine Drug Master File in Japan (Pirenzepine JDMF) empowers Pirenzepine 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 Pirenzepine JDMF during the approval evaluation for pharmaceutical products. At the time of Pirenzepine 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 Pirenzepine suppliers with JDMF 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 Pirenzepine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pirenzepine 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 Pirenzepine 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 Pirenzepine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pirenzepine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pirenzepine suppliers with NDC on PharmaCompass.
Pirenzepine 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 Pirenzepine 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 Pirenzepine GMP manufacturer or Pirenzepine GMP API supplier for your needs.
A Pirenzepine CoA (Certificate of Analysis) is a formal document that attests to Pirenzepine's compliance with Pirenzepine specifications and serves as a tool for batch-level quality control.
Pirenzepine CoA mostly includes findings from lab analyses of a specific batch. For each Pirenzepine 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.
Pirenzepine may be tested according to a variety of international standards, such as European Pharmacopoeia (Pirenzepine EP), Pirenzepine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pirenzepine USP).
LOOKING FOR A SUPPLIER?
Share
