Zoledronic Acid

Zoledronic Acid
Product Description

Zoledronic Acid

Monohydrate

> 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 DMF 
CANADIAN DMF, 
BRAZILIAN DMF



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.

Read 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
Categories
more categories Show less
Specifications
  • CAS Registry Number
    165800-06-6
  • Details
    Zoledronic Acid


    Monohydrate

    > 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 DMF 
    CANADIAN DMF, 
    BRAZILIAN DMF



    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
More specifications Fewer specifications

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

More Products from Polpharma S.A. (34)

  • Palbociclib

    Product Palbociclib

    Palbocyclib

    CRYSTAL FORM A
    US DMF pending

    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 liab...
  • Apixaban

    Product Apixaban

    Apixaban

    Polymorphic form N-1

    > No risk of nitrosamines > Eco friendly process
    > PSD flexibility via micronization

    EU DMF, 
    US DMF, 
    KOREAN DMF
    DISCLAIMER

    Products protected by va...
  • Empagliflozin

    Product Empagliflozin

    Empagliflozin

    CRYSTALLINE ANHYDROUS

    > Cryogenic process
    > Green chemistry

    EU DMF, 
    US DMF, 
    CHINESE DMF, 
    KOREAN DMF

    DISCLAIMER

    Products protected by valid patents...
  • Baclofen

    Product Baclofen

    Baclofen
    FORM B

    Own innovative process

    Global market leader
    CEP, US 
    DMF, 
    JAPANESE DMF, 
    KOREAN DMF, 
    CANADIAN DMF

    DISCLAIMER

    Products protected by valid patents are not offered for s...
  • Rivaroxaban

    Product Rivaroxaban

    Rivaroxaban

    MODIFICATION I

    > No risk of presence of nitrosamines
    > Innovative crystalization obtaining material of high purity

    CEP, 
    US DMF, 
    CHINESE DMF, 
    KOREAN DMF 
    DISCLAIMER ...
  • Trametinib

    Product Trametinib

    Trametinib

    DMSO solvate

    Oncology

    OEB 5
    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...
  • Piracetam

    Product Piracetam

    Piracetam
    Form II

    > Capacity and flexibility to cover high-volume demand
    oral & injectable forms

    CEP, 
    BRAZILIAN DMF"

    DISCLAIMER

    Products protected by valid patents are not offered for sale in cou...
  • Linagliptin

    Product Linagliptin

    Linagliptin

    Mix A&B

    > White API color
    > Better impurity profile


    DISCLAIMER

    Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. It ...
  • Elagolix sodium Amorphous form

    Product Elagolix sodium Amorphous form

    DISCLAIMER

    The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP...
  • Empagliflozin Crystalline anhydrous

    Product Empagliflozin Crystalline anhydrous

    DISCLAIMER

    The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP...
  • Linagliptin Mix of form A & B

    Product Linagliptin Mix of form A & B

    DISCLAIMER

    The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP...
  • Pimavanserin tartrate Crystalline anhydrous form C

    Product Pimavanserin tartrate Crystalline anhydrous form C

    DISCLAIMER

    The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP...
show all 34 other products

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.