Dapagliflozin

Dapagliflozin
Product Description

Dapagliflozin
amorphous & propanediol

> Cryogenic process
> Green Chemistry

EU DMF
US DMF
Korean DMF
Canadian 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.

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
Specifications
  • CAS Registry Number
    461432-26-8
  • Details
    Dapagliflozin

    amorphous & propanediol

    > Cryogenic process
    > Green Chemistry

    EU DMF
    US DMF
    Korean DMF
    Canadian 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

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

More Products from Polpharma S.A. (34)

  • Etodolac

    Product Etodolac

    Therapeutic Area: Musculo-skeletal systemEU DMF availableUS DMF no. 11405 availableJapanese DMF availableCEP available Indication: Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) used for the management of mild to moderate pain, fever, and inflammation.
  • Tadalafil

    Product Tadalafil

    Therapeutic area: genito-urinary system & sex hormones EU DMF available US DMF : 24590 CEP available
  • Ticagrelor

    Product Ticagrelor

    Ticagrelor 

    form II 

    Own process patent to free from nitrosamines 

    CEP, 
    US DMF, 
    EU DMF,  
    Korean DMF, 
    Canadian DMF, 
    Cadifa

    DISCLAIMER

    Products protected b...
  • Hydrochlorothiazide

    Product Hydrochlorothiazide

    Hydrochlorothiazide

    Therapeutic Area: Cardiovascular system • EU DMF available • US DMF no. 17599 available • Japanese DMF available  • CEP available  
    DISCLAIMER

    Products protected by valid patents are not offered for sale in countries where the sale of ...
  • Alendronate sodium

    Product Alendronate sodium

    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 D...
  • Pentoxifylline

    Product Pentoxifylline

    Pentoxifylline
    Form I

    > Very long production experience
    > Tailor made PSD

    CEP, 
    US DMF, 
    CHINESE


    This product is not offered for sale or made available in countries where it is subject to patent (SP...
  • Enzaluthamide

    Product Enzaluthamide

    Enzalutamide 
    Anhydrous form R1 

    CAS No: 915087-33-1
    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 respon...
  • 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 ...

Polpharma S.A. resources (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? 
  • 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.