PREDNISOLONE

top product with cep and eu-gmp

TWO MICRONIZATION GRADES AVAILABLE

PREDNISOLONE (CAS 50-24-8) is a synthetic glucocorticoid, a derivative of cortisol, which is used to treat a variety of inflammatory and auto-immune conditions.

THERAPEUTIC INDICATION: ANTI- INFLAMMATORY/IMMUNOSUPPRESSANT AGENT

PREDNISOLONE is prescribed for the treatment of a wide range of inflammatory and auto-immune conditions such as

  • asthma,
  • uveitis,
  • rheumatoid arthritis,
  • pericarditis,
  • Crohn's disease,
  • multiple sclerosis,
  • cluster headaches,
  • systemic lupus erythematosus, etc.

MARKET INFORMATION

Originator: BAYER
Originator product: RINOBANEDIF® nasal cream

 

REGULATORY STATUS

PREDNISOLONE BASE

GMP: YES with EU
US-DMF: NO
EU-DMF: YES
COA: EP
CEP: YES
TSE/BSE: YES

 

PREDNISOLONE SALTS
Sodium Phosphate and Acetate

GMP: All YES with EU-WC
US-DMF: NA
EU-DMF: YES
COA: EP
CEP: Phosphate NO; Acetate submitted
TSE/BSE: YES

YOUR ADVANTAGES

  • Product with CEP and EU-GMP (Denmark)
  • Two micronization grades available
  • Used in human as well as in veterinary products

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