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PharmaCompass offers a list of Tobramycin 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 Tobramycin manufacturer or Tobramycin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tobramycin manufacturer or Tobramycin supplier.
PharmaCompass also assists you with knowing the Tobramycin API Price utilized in the formulation of products. Tobramycin API Price is not always fixed or binding as the Tobramycin Price is obtained through a variety of data sources. The Tobramycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alveoterol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alveoterol, including repackagers and relabelers. The FDA regulates Alveoterol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alveoterol 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 Alveoterol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alveoterol supplier is an individual or a company that provides Alveoterol active pharmaceutical ingredient (API) or Alveoterol finished formulations upon request. The Alveoterol suppliers may include Alveoterol API manufacturers, exporters, distributors and traders.
click here to find a list of Alveoterol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alveoterol DMF (Drug Master File) is a document detailing the whole manufacturing process of Alveoterol active pharmaceutical ingredient (API) in detail. Different forms of Alveoterol DMFs exist exist since differing nations have different regulations, such as Alveoterol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alveoterol DMF submitted to regulatory agencies in the US is known as a USDMF. Alveoterol USDMF includes data on Alveoterol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alveoterol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alveoterol 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 Alveoterol Drug Master File in Japan (Alveoterol JDMF) empowers Alveoterol 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 Alveoterol JDMF during the approval evaluation for pharmaceutical products. At the time of Alveoterol 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 Alveoterol 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 Alveoterol Drug Master File in Korea (Alveoterol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alveoterol. The MFDS reviews the Alveoterol KDMF as part of the drug registration process and uses the information provided in the Alveoterol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alveoterol 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 Alveoterol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alveoterol suppliers with KDMF on PharmaCompass.
A Alveoterol CEP of the European Pharmacopoeia monograph is often referred to as a Alveoterol Certificate of Suitability (COS). The purpose of a Alveoterol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alveoterol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alveoterol to their clients by showing that a Alveoterol CEP has been issued for it. The manufacturer submits a Alveoterol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alveoterol CEP holder for the record. Additionally, the data presented in the Alveoterol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alveoterol DMF.
A Alveoterol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alveoterol 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 Alveoterol suppliers with CEP (COS) 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 Alveoterol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alveoterol 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 Alveoterol 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 Alveoterol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alveoterol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alveoterol suppliers with NDC on PharmaCompass.
Alveoterol 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 Alveoterol 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 Alveoterol GMP manufacturer or Alveoterol GMP API supplier for your needs.
A Alveoterol CoA (Certificate of Analysis) is a formal document that attests to Alveoterol's compliance with Alveoterol specifications and serves as a tool for batch-level quality control.
Alveoterol CoA mostly includes findings from lab analyses of a specific batch. For each Alveoterol 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.
Alveoterol may be tested according to a variety of international standards, such as European Pharmacopoeia (Alveoterol EP), Alveoterol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alveoterol USP).
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