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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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JDMF
ASMF, CA
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
ASMF, RU
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
ASMF
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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- INJECTABLE;INTRAVENOUS - EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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Chewable & Orodispersible Aids
Direct Compression
Taste Masking
Disintegrants & Superdisintegrants
Parenteral
Co-Processed Excipients
Granulation
Controlled & Modified Release
Solubilizers
Thickeners and Stabilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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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 Aclasta and Reclast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aclasta and Reclast, including repackagers and relabelers. The FDA regulates Aclasta and Reclast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aclasta and 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 Aclasta and Reclast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aclasta and Reclast supplier is an individual or a company that provides Aclasta and Reclast active pharmaceutical ingredient (API) or Aclasta and Reclast finished formulations upon request. The Aclasta and Reclast suppliers may include Aclasta and Reclast API manufacturers, exporters, distributors and traders.
click here to find a list of Aclasta and Reclast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aclasta and Reclast DMF (Drug Master File) is a document detailing the whole manufacturing process of Aclasta and Reclast active pharmaceutical ingredient (API) in detail. Different forms of Aclasta and Reclast DMFs exist exist since differing nations have different regulations, such as Aclasta and Reclast USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aclasta and Reclast DMF submitted to regulatory agencies in the US is known as a USDMF. Aclasta and Reclast USDMF includes data on Aclasta and Reclast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aclasta and Reclast USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aclasta and 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 Aclasta and Reclast Drug Master File in Japan (Aclasta and Reclast JDMF) empowers Aclasta and 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 Aclasta and Reclast JDMF during the approval evaluation for pharmaceutical products. At the time of Aclasta and 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 Aclasta and 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 Aclasta and Reclast Drug Master File in Korea (Aclasta and Reclast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aclasta and Reclast. The MFDS reviews the Aclasta and Reclast KDMF as part of the drug registration process and uses the information provided in the Aclasta and Reclast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aclasta and 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 Aclasta and Reclast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aclasta and Reclast suppliers with KDMF on PharmaCompass.
A Aclasta and Reclast CEP of the European Pharmacopoeia monograph is often referred to as a Aclasta and Reclast Certificate of Suitability (COS). The purpose of a Aclasta and Reclast CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aclasta and Reclast EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aclasta and Reclast to their clients by showing that a Aclasta and Reclast CEP has been issued for it. The manufacturer submits a Aclasta and Reclast CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aclasta and Reclast CEP holder for the record. Additionally, the data presented in the Aclasta and Reclast CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aclasta and Reclast DMF.
A Aclasta and Reclast CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aclasta and 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 Aclasta and Reclast suppliers with CEP (COS) on PharmaCompass.
A Aclasta and Reclast written confirmation (Aclasta and Reclast WC) is an official document issued by a regulatory agency to a Aclasta and Reclast manufacturer, verifying that the manufacturing facility of a Aclasta and Reclast active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aclasta and Reclast APIs or Aclasta and Reclast finished pharmaceutical products to another nation, regulatory agencies frequently require a Aclasta and Reclast WC (written confirmation) as part of the regulatory process.
click here to find a list of Aclasta and 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 Aclasta and Reclast as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aclasta and 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 Aclasta and 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 Aclasta and Reclast and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aclasta and Reclast NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aclasta and Reclast suppliers with NDC on PharmaCompass.
Aclasta and 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 Aclasta and 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 Aclasta and Reclast GMP manufacturer or Aclasta and Reclast GMP API supplier for your needs.
A Aclasta and Reclast CoA (Certificate of Analysis) is a formal document that attests to Aclasta and Reclast's compliance with Aclasta and Reclast specifications and serves as a tool for batch-level quality control.
Aclasta and Reclast CoA mostly includes findings from lab analyses of a specific batch. For each Aclasta and 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.
Aclasta and Reclast may be tested according to a variety of international standards, such as European Pharmacopoeia (Aclasta and Reclast EP), Aclasta and Reclast JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aclasta and Reclast USP).
