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API SUPPLIERS
Inke S.A: APIs manufacturing plant.
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ASMF
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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USDMF
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-14
Pay. Date : 2023-04-21
DMF Number : 36437
Submission : 2023-03-16
Status :
Type : II
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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...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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DOSAGE - POWDER, METERED;INHALATION - 0.4MG/I...DOSAGE - POWDER, METERED;INHALATION - 0.4MG/INH
USFDA APPLICATION NUMBER - 202450
DOSAGE - POWDER, METERED;INHALATION - 0.4MG/I...DOSAGE - POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH
USFDA APPLICATION NUMBER - 210595
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A Aclidinium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aclidinium Bromide, including repackagers and relabelers. The FDA regulates Aclidinium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aclidinium 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 Aclidinium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aclidinium Bromide supplier is an individual or a company that provides Aclidinium Bromide active pharmaceutical ingredient (API) or Aclidinium Bromide finished formulations upon request. The Aclidinium Bromide suppliers may include Aclidinium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Aclidinium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aclidinium Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Aclidinium Bromide active pharmaceutical ingredient (API) in detail. Different forms of Aclidinium Bromide DMFs exist exist since differing nations have different regulations, such as Aclidinium Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aclidinium Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Aclidinium Bromide USDMF includes data on Aclidinium Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aclidinium Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aclidinium 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 Aclidinium Bromide Drug Master File in Japan (Aclidinium Bromide JDMF) empowers Aclidinium 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 Aclidinium Bromide JDMF during the approval evaluation for pharmaceutical products. At the time of Aclidinium 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 Aclidinium 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 Aclidinium Bromide Drug Master File in Korea (Aclidinium Bromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aclidinium Bromide. The MFDS reviews the Aclidinium Bromide KDMF as part of the drug registration process and uses the information provided in the Aclidinium Bromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aclidinium 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 Aclidinium Bromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aclidinium Bromide suppliers with KDMF on PharmaCompass.
A Aclidinium Bromide written confirmation (Aclidinium Bromide WC) is an official document issued by a regulatory agency to a Aclidinium Bromide manufacturer, verifying that the manufacturing facility of a Aclidinium Bromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aclidinium Bromide APIs or Aclidinium Bromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Aclidinium Bromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Aclidinium 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 Aclidinium Bromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aclidinium 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 Aclidinium 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 Aclidinium Bromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aclidinium Bromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aclidinium Bromide suppliers with NDC on PharmaCompass.
Aclidinium 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 Aclidinium 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 Aclidinium Bromide GMP manufacturer or Aclidinium Bromide GMP API supplier for your needs.
A Aclidinium Bromide CoA (Certificate of Analysis) is a formal document that attests to Aclidinium Bromide's compliance with Aclidinium Bromide specifications and serves as a tool for batch-level quality control.
Aclidinium Bromide CoA mostly includes findings from lab analyses of a specific batch. For each Aclidinium 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.
Aclidinium Bromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Aclidinium Bromide EP), Aclidinium Bromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aclidinium Bromide USP).
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