Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Click Us!
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.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Certificate Number : R1-CEP 2003-273 - Rev 04
Status : Valid
Issue Date : 2021-05-12
Type : Chemical
Substance Number : 1564
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 2004-215 - Rev 04
Status : Valid
Issue Date : 2019-01-04
Type : Chemical
Substance Number : 1564
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Disintegrants & Superdisintegrants
Direct Compression
Taste Masking
Co-Processed Excipients
Granulation
Thickeners and Stabilizers
Chewable & Orodispersible Aids
Lubricants & Glidants
Empty Capsules
Coating Systems & Additives
Parenteral
Controlled & Modified Release
API Stability Enhancers
Solubilizers
Emulsifying Agents
Topical
Rheology Modifiers
Film Formers & Plasticizers
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
47
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 SODIUM ALDENDRONATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SODIUM ALDENDRONATE, including repackagers and relabelers. The FDA regulates SODIUM ALDENDRONATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SODIUM ALDENDRONATE supplier is an individual or a company that provides SODIUM ALDENDRONATE active pharmaceutical ingredient (API) or SODIUM ALDENDRONATE finished formulations upon request. The SODIUM ALDENDRONATE suppliers may include SODIUM ALDENDRONATE API manufacturers, exporters, distributors and traders.
click here to find a list of SODIUM ALDENDRONATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SODIUM ALDENDRONATE DMF (Drug Master File) is a document detailing the whole manufacturing process of SODIUM ALDENDRONATE active pharmaceutical ingredient (API) in detail. Different forms of SODIUM ALDENDRONATE DMFs exist exist since differing nations have different regulations, such as SODIUM ALDENDRONATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SODIUM ALDENDRONATE DMF submitted to regulatory agencies in the US is known as a USDMF. SODIUM ALDENDRONATE USDMF includes data on SODIUM ALDENDRONATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SODIUM ALDENDRONATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE Drug Master File in Japan (SODIUM ALDENDRONATE JDMF) empowers SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE JDMF during the approval evaluation for pharmaceutical products. At the time of SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE Drug Master File in Korea (SODIUM ALDENDRONATE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SODIUM ALDENDRONATE. The MFDS reviews the SODIUM ALDENDRONATE KDMF as part of the drug registration process and uses the information provided in the SODIUM ALDENDRONATE KDMF to evaluate the safety and efficacy of the drug.
After submitting a SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SODIUM ALDENDRONATE suppliers with KDMF on PharmaCompass.
A SODIUM ALDENDRONATE CEP of the European Pharmacopoeia monograph is often referred to as a SODIUM ALDENDRONATE Certificate of Suitability (COS). The purpose of a SODIUM ALDENDRONATE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SODIUM ALDENDRONATE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SODIUM ALDENDRONATE to their clients by showing that a SODIUM ALDENDRONATE CEP has been issued for it. The manufacturer submits a SODIUM ALDENDRONATE CEP (COS) as part of the market authorization procedure, and it takes on the role of a SODIUM ALDENDRONATE CEP holder for the record. Additionally, the data presented in the SODIUM ALDENDRONATE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SODIUM ALDENDRONATE DMF.
A SODIUM ALDENDRONATE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE suppliers with CEP (COS) on PharmaCompass.
A SODIUM ALDENDRONATE written confirmation (SODIUM ALDENDRONATE WC) is an official document issued by a regulatory agency to a SODIUM ALDENDRONATE manufacturer, verifying that the manufacturing facility of a SODIUM ALDENDRONATE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SODIUM ALDENDRONATE APIs or SODIUM ALDENDRONATE finished pharmaceutical products to another nation, regulatory agencies frequently require a SODIUM ALDENDRONATE WC (written confirmation) as part of the regulatory process.
click here to find a list of SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SODIUM ALDENDRONATE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SODIUM ALDENDRONATE suppliers with NDC on PharmaCompass.
SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE 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 SODIUM ALDENDRONATE GMP manufacturer or SODIUM ALDENDRONATE GMP API supplier for your needs.
A SODIUM ALDENDRONATE CoA (Certificate of Analysis) is a formal document that attests to SODIUM ALDENDRONATE's compliance with SODIUM ALDENDRONATE specifications and serves as a tool for batch-level quality control.
SODIUM ALDENDRONATE CoA mostly includes findings from lab analyses of a specific batch. For each SODIUM ALDENDRONATE 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.
SODIUM ALDENDRONATE may be tested according to a variety of international standards, such as European Pharmacopoeia (SODIUM ALDENDRONATE EP), SODIUM ALDENDRONATE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SODIUM ALDENDRONATE USP).
