Medicines/finished pharmaceutical products

Reference Number: 
RH050

Date of prequalification: 
30 June 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Oxytocin
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Solution for injection 10IU/mL
Storage condition: 
Store in a refrigerator (2 °C to 8 °C), do not freeze, protect from light
Shelf life (months): 
18
Packaging: 
Ampoule, Type I glass 1mLx10
Applicant: 
PT Sanbe Farma, Jl. Taman Sari No 10, Bandung, 40116, Indonesia
FPP Manufacturing Site: 

PT Sanbe Farma, Sterile Preparation Plant, Unit 3, Jl. Industri Cimarene No. 8, Desa Cimareme, Kecamatan Ngamprah, Kabupaten Bandung Barat, 40553, Indonesia

API Manufacturing Site: 

(Oxytocin) Grindeks JSC, 53 Krustpils Street, Riga, 1057, Latvia

API WHO Public Inspection Reports: