Cephalosporins - Injectables

Product | Pharmacopeia | US DMF | EDMF | COS | Others |
---|---|---|---|---|---|
Arginine (Sterile Bulk) | US/JP/EP | √ | ✕ | ✕ | Applicant part DMF |
Sodium Carbonate (Sterile) | US/JP/EP | √ | ✕ | ✕ | ✕ |
Cefotaxime Sodium (Sterile) | USP/EP/BP/JP | √ | √ | √ | Applicant part DMF as per COS |
Ceftriaxone Sodium (Sterile) | USP/EP/JP | √ | √ | √ | Canada DMF/JDMF/Applicant part DMF as per COS |
Ceftazidime Pentahydrate (sterile) | USP/EP/JP | √ | ✕ | √ | Applicant part DMF as per COS |
Ceftazidime Pentahydrate with Sodium Carbonate for Injection | USP/EP/BP/JP | √ | √ | √ | Applicant part DMF as per COS |
Cefazolin Sodium (Sterile) | USP / EP/BP/JP | √ | √ | √ | Canada DMF/JDMF/Applicant part DMF as per COS |
Cefoxitin Sodium (Sterile) | USP / EP/BP | √ | √ | √ | Applicant part DMF as per COS |
Cefepime Hydrochloride (Sterile) | USP / EP/JP | √ | ✕ | √ | Canada DMF/JDMF/Applicant part DMF as per COS |
Cefepime + Arginine (Sterile) | USP / EP/JP | √ | √ | ✕ | Canada DMF/JDMF |
Cefpirome Sulphate | In-house/JP | ✕ | ✕ | ✕ | Applicant part DMF |
Cefuroxime Sodium (Sterile) | USP / EP | ✕ | TIP | ✕ | Australia DMF |
Ceforanide + L-Lysine | In-house/USP | ✕ | ✕ | ✕ | Applicant part DMF |
Cefalothin Sodium Buffered (Sterile) | USP/EP | ✕ | TIP | ✕ | Australia DMF |
Ceftizoxime Sodium (Sterile) | USP | ✕ | ✕ | ✕ | Applicant part DMF |
Cefoperazone Sodium (Sterile) | In-house/JP / EP | TIP | TIP | ✕ | ✕ |
Cefotiam Hexetil | In-house/JP | - | - | ✕ | ✕ |
Cefotiam Hydrochloride | In-house/JP | - | - | ✕ | ✕ |
Cefozopran Hydrochloride | In-house/JP | - | - | ✕ | ✕ |
Sterile Procesing Details of Phase-18,Alathur,India(Type-V USDMF) | - | √ | ✕ | ✕ | ✕ |
US DMF-US Drug Master File |
COS- Certificate of Suitability |
USP- United States Pharmacopeia |
JP- Japanese Pharmacopeia |
TIP- Technical Information Package |
EP- European Pharmacopeia |
BP- British Pharmacopeia |
EDMF- European Drug Master File |
JDMF - Japan Drug Master File |
Disclaimer
Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute as an offer for sales in territories where it is not permitted by law.