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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Inke S.A: APIs manufacturing plant.
Glycopyrronium Bromide, Micronised, Non-micronis...
Certificate Number : R1-CEP 2017-182 - Rev 00
Status : Valid
Issue Date : 2023-08-17
Type : Chemical
Substance Number : 1783
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Certificate Number : R1-CEP 2012-129 - Rev 01
Status : Valid
Issue Date : 2020-07-30
Type : Chemical
Substance Number : 1783
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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**Fe...DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Glycopyrronium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycopyrronium Bromide, including repackagers and relabelers. The FDA regulates Glycopyrronium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycopyrronium Bromide 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 Glycopyrronium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycopyrronium Bromide supplier is an individual or a company that provides Glycopyrronium Bromide active pharmaceutical ingredient (API) or Glycopyrronium Bromide finished formulations upon request. The Glycopyrronium Bromide suppliers may include Glycopyrronium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Glycopyrronium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycopyrronium Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycopyrronium Bromide active pharmaceutical ingredient (API) in detail. Different forms of Glycopyrronium Bromide DMFs exist exist since differing nations have different regulations, such as Glycopyrronium Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycopyrronium Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Glycopyrronium Bromide USDMF includes data on Glycopyrronium Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycopyrronium Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycopyrronium Bromide 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 Glycopyrronium Bromide Drug Master File in Japan (Glycopyrronium Bromide JDMF) empowers Glycopyrronium Bromide 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 Glycopyrronium Bromide JDMF during the approval evaluation for pharmaceutical products. At the time of Glycopyrronium Bromide 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 Glycopyrronium Bromide 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 Glycopyrronium Bromide Drug Master File in Korea (Glycopyrronium Bromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Glycopyrronium Bromide. The MFDS reviews the Glycopyrronium Bromide KDMF as part of the drug registration process and uses the information provided in the Glycopyrronium Bromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Glycopyrronium Bromide 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 Glycopyrronium Bromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Glycopyrronium Bromide suppliers with KDMF on PharmaCompass.
A Glycopyrronium Bromide CEP of the European Pharmacopoeia monograph is often referred to as a Glycopyrronium Bromide Certificate of Suitability (COS). The purpose of a Glycopyrronium Bromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glycopyrronium Bromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glycopyrronium Bromide to their clients by showing that a Glycopyrronium Bromide CEP has been issued for it. The manufacturer submits a Glycopyrronium Bromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glycopyrronium Bromide CEP holder for the record. Additionally, the data presented in the Glycopyrronium Bromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glycopyrronium Bromide DMF.
A Glycopyrronium Bromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glycopyrronium Bromide 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 Glycopyrronium Bromide suppliers with CEP (COS) on PharmaCompass.
A Glycopyrronium Bromide written confirmation (Glycopyrronium Bromide WC) is an official document issued by a regulatory agency to a Glycopyrronium Bromide manufacturer, verifying that the manufacturing facility of a Glycopyrronium Bromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Glycopyrronium Bromide APIs or Glycopyrronium Bromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Glycopyrronium Bromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Glycopyrronium Bromide 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 Glycopyrronium Bromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glycopyrronium Bromide 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 Glycopyrronium Bromide 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 Glycopyrronium Bromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glycopyrronium Bromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glycopyrronium Bromide suppliers with NDC on PharmaCompass.
Glycopyrronium Bromide 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 Glycopyrronium Bromide 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 Glycopyrronium Bromide GMP manufacturer or Glycopyrronium Bromide GMP API supplier for your needs.
A Glycopyrronium Bromide CoA (Certificate of Analysis) is a formal document that attests to Glycopyrronium Bromide's compliance with Glycopyrronium Bromide specifications and serves as a tool for batch-level quality control.
Glycopyrronium Bromide CoA mostly includes findings from lab analyses of a specific batch. For each Glycopyrronium Bromide 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.
Glycopyrronium Bromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Glycopyrronium Bromide EP), Glycopyrronium Bromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glycopyrronium Bromide USP).
