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API SUPPLIERS
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USDMF
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-16
Pay. Date : 2017-07-06
DMF Number : 31836
Submission : 2017-07-22
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-30
DMF Number : 18106
Submission : 2005-02-22
Status :
Type : II
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DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 12827
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 12827
DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML **Fe...DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17558
DOSAGE - POWDER;INHALATION - 15.6MCG/INH
USFDA APPLICATION NUMBER - 207923
DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5...DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH
USFDA APPLICATION NUMBER - 207930
DOSAGE - SOLUTION;INHALATION - 25MCG/ML
USFDA APPLICATION NUMBER - 208437
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG
USFDA APPLICATION NUMBER - 215019
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ABOUT THIS PAGE
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PharmaCompass offers a list of Glycopyrronium Bromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Glycopyrronium Bromide manufacturer or Glycopyrronium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glycopyrronium Bromide manufacturer or Glycopyrronium Bromide supplier.
PharmaCompass also assists you with knowing the Glycopyrronium Bromide API Price utilized in the formulation of products. Glycopyrronium Bromide API Price is not always fixed or binding as the Glycopyrronium Bromide Price is obtained through a variety of data sources. The Glycopyrronium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bromuro de glicopirronio manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromuro de glicopirronio, including repackagers and relabelers. The FDA regulates Bromuro de glicopirronio manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromuro de glicopirronio 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 Bromuro de glicopirronio manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromuro de glicopirronio supplier is an individual or a company that provides Bromuro de glicopirronio active pharmaceutical ingredient (API) or Bromuro de glicopirronio finished formulations upon request. The Bromuro de glicopirronio suppliers may include Bromuro de glicopirronio API manufacturers, exporters, distributors and traders.
click here to find a list of Bromuro de glicopirronio suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bromuro de glicopirronio DMF (Drug Master File) is a document detailing the whole manufacturing process of Bromuro de glicopirronio active pharmaceutical ingredient (API) in detail. Different forms of Bromuro de glicopirronio DMFs exist exist since differing nations have different regulations, such as Bromuro de glicopirronio USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bromuro de glicopirronio DMF submitted to regulatory agencies in the US is known as a USDMF. Bromuro de glicopirronio USDMF includes data on Bromuro de glicopirronio's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bromuro de glicopirronio USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bromuro de glicopirronio 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 Bromuro de glicopirronio Drug Master File in Japan (Bromuro de glicopirronio JDMF) empowers Bromuro de glicopirronio 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 Bromuro de glicopirronio JDMF during the approval evaluation for pharmaceutical products. At the time of Bromuro de glicopirronio 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 Bromuro de glicopirronio suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Bromuro de glicopirronio Drug Master File in Korea (Bromuro de glicopirronio KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bromuro de glicopirronio. The MFDS reviews the Bromuro de glicopirronio KDMF as part of the drug registration process and uses the information provided in the Bromuro de glicopirronio KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bromuro de glicopirronio KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Bromuro de glicopirronio API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bromuro de glicopirronio suppliers with KDMF on PharmaCompass.
A Bromuro de glicopirronio CEP of the European Pharmacopoeia monograph is often referred to as a Bromuro de glicopirronio Certificate of Suitability (COS). The purpose of a Bromuro de glicopirronio CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bromuro de glicopirronio EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bromuro de glicopirronio to their clients by showing that a Bromuro de glicopirronio CEP has been issued for it. The manufacturer submits a Bromuro de glicopirronio CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bromuro de glicopirronio CEP holder for the record. Additionally, the data presented in the Bromuro de glicopirronio CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bromuro de glicopirronio DMF.
A Bromuro de glicopirronio CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bromuro de glicopirronio 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 Bromuro de glicopirronio suppliers with CEP (COS) on PharmaCompass.
A Bromuro de glicopirronio written confirmation (Bromuro de glicopirronio WC) is an official document issued by a regulatory agency to a Bromuro de glicopirronio manufacturer, verifying that the manufacturing facility of a Bromuro de glicopirronio active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bromuro de glicopirronio APIs or Bromuro de glicopirronio finished pharmaceutical products to another nation, regulatory agencies frequently require a Bromuro de glicopirronio WC (written confirmation) as part of the regulatory process.
click here to find a list of Bromuro de glicopirronio 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 Bromuro de glicopirronio as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bromuro de glicopirronio 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 Bromuro de glicopirronio 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 Bromuro de glicopirronio and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bromuro de glicopirronio NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bromuro de glicopirronio suppliers with NDC on PharmaCompass.
Bromuro de glicopirronio 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 Bromuro de glicopirronio 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 Bromuro de glicopirronio GMP manufacturer or Bromuro de glicopirronio GMP API supplier for your needs.
A Bromuro de glicopirronio CoA (Certificate of Analysis) is a formal document that attests to Bromuro de glicopirronio's compliance with Bromuro de glicopirronio specifications and serves as a tool for batch-level quality control.
Bromuro de glicopirronio CoA mostly includes findings from lab analyses of a specific batch. For each Bromuro de glicopirronio 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.
Bromuro de glicopirronio may be tested according to a variety of international standards, such as European Pharmacopoeia (Bromuro de glicopirronio EP), Bromuro de glicopirronio JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bromuro de glicopirronio USP).
