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API SUPPLIERS
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USDMF
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API Imports and Exports
Drugs in Development
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DOSAGE - INJECTABLE;INTRAVENOUS - EQ 4MG BASE...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 4MG BASE/100ML
USFDA APPLICATION NUMBER - 203231
DOSAGE - INJECTABLE;INTRAVENOUS - EQ 4MG BASE...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21223
Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 Reclast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Reclast, including repackagers and relabelers. The FDA regulates Reclast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Reclast 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 Reclast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Reclast supplier is an individual or a company that provides Reclast active pharmaceutical ingredient (API) or Reclast finished formulations upon request. The Reclast suppliers may include Reclast API manufacturers, exporters, distributors and traders.
click here to find a list of Reclast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Reclast DMF (Drug Master File) is a document detailing the whole manufacturing process of Reclast active pharmaceutical ingredient (API) in detail. Different forms of Reclast DMFs exist exist since differing nations have different regulations, such as Reclast USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Reclast DMF submitted to regulatory agencies in the US is known as a USDMF. Reclast USDMF includes data on Reclast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Reclast USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Reclast 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 Reclast Drug Master File in Japan (Reclast JDMF) empowers Reclast 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 Reclast JDMF during the approval evaluation for pharmaceutical products. At the time of Reclast 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 Reclast 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 Reclast Drug Master File in Korea (Reclast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Reclast. The MFDS reviews the Reclast KDMF as part of the drug registration process and uses the information provided in the Reclast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Reclast 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 Reclast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Reclast suppliers with KDMF on PharmaCompass.
A Reclast CEP of the European Pharmacopoeia monograph is often referred to as a Reclast Certificate of Suitability (COS). The purpose of a Reclast CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Reclast EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Reclast to their clients by showing that a Reclast CEP has been issued for it. The manufacturer submits a Reclast CEP (COS) as part of the market authorization procedure, and it takes on the role of a Reclast CEP holder for the record. Additionally, the data presented in the Reclast CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Reclast DMF.
A Reclast CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Reclast 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 Reclast suppliers with CEP (COS) on PharmaCompass.
A Reclast written confirmation (Reclast WC) is an official document issued by a regulatory agency to a Reclast manufacturer, verifying that the manufacturing facility of a Reclast active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Reclast APIs or Reclast finished pharmaceutical products to another nation, regulatory agencies frequently require a Reclast WC (written confirmation) as part of the regulatory process.
click here to find a list of Reclast 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 Reclast as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Reclast 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 Reclast 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 Reclast and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Reclast NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Reclast suppliers with NDC on PharmaCompass.
Reclast 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 Reclast 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 Reclast GMP manufacturer or Reclast GMP API supplier for your needs.
A Reclast CoA (Certificate of Analysis) is a formal document that attests to Reclast's compliance with Reclast specifications and serves as a tool for batch-level quality control.
Reclast CoA mostly includes findings from lab analyses of a specific batch. For each Reclast 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.
Reclast may be tested according to a variety of international standards, such as European Pharmacopoeia (Reclast EP), Reclast JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Reclast USP).
