PREDNISOLONE
top product with cep and eu-gmpTWO 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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