Product details
WHO Product ID
WHOAPI-356
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Sulfadoxine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Mangalam Drugs & Organics Ltd
Rupam Building, 3rd Floor, 239 P.D'mello Rd, near GPO
Mumbai,
Maharashtra
400 001
India
APIMF Version Number
MDOL/SFD/OP-2022/00
MDOL/SFD/RP-2022/00
MDOL/SFD/OP-2022/01
MDOL/SFD/RP-2022/00
MDOL/SFD/OP-2022/01
Product Grades
API specification number
DS.SP.IH.SFD-D Version no. 1.2
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Shelf life
Packaging
Clear/transparent polyethylene bag (LDPE) inserted in a black colored single polyethylene bag (LDPE) and placed in HDPE drum.
API Manufacturing Site(s)
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India