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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
NDC
ASMF, CA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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.
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
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USDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 16962
Submission : 2003-11-17
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20443
Submission : 2007-04-17
Status :
Type : II
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
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...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
About the Company : JPN Pharma is a premier pharmaceutical company in India, specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headq...
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
About the Company : Apex Healthcare Limited, established in 2002, is a trusted manufacturer and exporter of APIs, bulk drugs, and formulations, based in Ankleshwar, India’s largest chemical industri...
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DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 35MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 40MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 70MG BASE
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 70MG BASE;2,800 IU
USFDA APPLICATION NUMBER - 21762
DOSAGE - TABLET;ORAL - EQ 70MG BASE;5,600 IU
USFDA APPLICATION NUMBER - 21762
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ABOUT THIS PAGE
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PharmaCompass offers a list of Alendronate Sodium 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 Alendronate Sodium manufacturer or Alendronate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alendronate Sodium manufacturer or Alendronate Sodium supplier.
PharmaCompass also assists you with knowing the Alendronate Sodium API Price utilized in the formulation of products. Alendronate Sodium API Price is not always fixed or binding as the Alendronate Sodium Price is obtained through a variety of data sources. The Alendronate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Adronat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adronat, including repackagers and relabelers. The FDA regulates Adronat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adronat 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 Adronat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Adronat supplier is an individual or a company that provides Adronat active pharmaceutical ingredient (API) or Adronat finished formulations upon request. The Adronat suppliers may include Adronat API manufacturers, exporters, distributors and traders.
click here to find a list of Adronat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Adronat DMF (Drug Master File) is a document detailing the whole manufacturing process of Adronat active pharmaceutical ingredient (API) in detail. Different forms of Adronat DMFs exist exist since differing nations have different regulations, such as Adronat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Adronat DMF submitted to regulatory agencies in the US is known as a USDMF. Adronat USDMF includes data on Adronat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Adronat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Adronat 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 Adronat Drug Master File in Japan (Adronat JDMF) empowers Adronat 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 Adronat JDMF during the approval evaluation for pharmaceutical products. At the time of Adronat 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 Adronat 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 Adronat Drug Master File in Korea (Adronat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Adronat. The MFDS reviews the Adronat KDMF as part of the drug registration process and uses the information provided in the Adronat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Adronat 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 Adronat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Adronat suppliers with KDMF on PharmaCompass.
A Adronat CEP of the European Pharmacopoeia monograph is often referred to as a Adronat Certificate of Suitability (COS). The purpose of a Adronat CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Adronat EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Adronat to their clients by showing that a Adronat CEP has been issued for it. The manufacturer submits a Adronat CEP (COS) as part of the market authorization procedure, and it takes on the role of a Adronat CEP holder for the record. Additionally, the data presented in the Adronat CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Adronat DMF.
A Adronat CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Adronat 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 Adronat suppliers with CEP (COS) on PharmaCompass.
A Adronat written confirmation (Adronat WC) is an official document issued by a regulatory agency to a Adronat manufacturer, verifying that the manufacturing facility of a Adronat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Adronat APIs or Adronat finished pharmaceutical products to another nation, regulatory agencies frequently require a Adronat WC (written confirmation) as part of the regulatory process.
click here to find a list of Adronat 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 Adronat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Adronat 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 Adronat 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 Adronat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Adronat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Adronat suppliers with NDC on PharmaCompass.
Adronat 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 Adronat 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 Adronat GMP manufacturer or Adronat GMP API supplier for your needs.
A Adronat CoA (Certificate of Analysis) is a formal document that attests to Adronat's compliance with Adronat specifications and serves as a tool for batch-level quality control.
Adronat CoA mostly includes findings from lab analyses of a specific batch. For each Adronat 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.
Adronat may be tested according to a variety of international standards, such as European Pharmacopoeia (Adronat EP), Adronat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Adronat USP).
