Alendronate sodium

Alendronate sodium
Product Description

Alendronate Sodium
Trihydrate

> No risk of presence of nitrosamines
> Long experience with commercial manufacturing
> In-house production of the whole product family (Risedronate, Alendronate, Ibandronate)

CEP, 
US DMF, 
JAPANESE, 
KOREAN, 
CANADIAN, 
BRAZILIAN

DISCLAIMER
Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s).

Products protected by patents in force in Poland are developed solely for the purpose of Regulatory Submissions.


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Polpharma S.A.

  • PL
  • 2015
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Service
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Pharmaceutical company
View company profile
Categories
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Specifications
  • CAS Registry Number
    121268-17-5
  • Details
    Alendronate Sodium
    Trihydrate

    > No risk of presence of nitrosamines
    > Long experience with commercial manufacturing
    > In-house production of the whole product family (Risedronate, Alendronate, Ibandronate)

    CEP, US DMF, JAPANESE, KOREAN, CANADIAN, BRAZILIAN
    This product is not offered for sale or made available in countries where it is subject to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s).
    DISCLAIMER

    Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s).

    Products protected by patents in force in Poland are developed solely for the purpose of Regulatory Submissions.

  • Selling Points
    ✔️ HP API (OEL up to 10 ng/m3)
    ✔️ EU manufacturing site
    ✔️ US FDA-approved
    ✔️ 70 years of experience in small molecules
    ✔️ cGMP manufacturing
    ✔️ Highest quality standards
    ✔️ Research, Development, and Commercial Manufacturing
    ✔️ World-class regulatory support
    ✔️ Smooth and transparent cooperation
  • Supplied from
    Poland
  • Measured In
    gram; kilogram
More specifications Fewer specifications
Sales Markets
Show more Show less

Polpharma S.A.

  • PL
  • 2015
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Service
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Pharmaceutical company
View company profile

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Polpharma S.A. resources (2)

  • CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2

    News CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2

    This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? 
    15 Nov 2023
  • API Product List 2024

    Brochure API Product List 2024

    We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.