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