Product details
WHO Product ID
WHOAPI-151
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Dihydroartemisinin
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/DHA/OP-2021/00
MDOL/DHA/RP-2021/00
MDOL/DHA/RP-2021/01
MDOL/DHA/RP-2021/02
MDOL/DHA/RP-2021/00
MDOL/DHA/RP-2021/01
MDOL/DHA/RP-2021/02
Product Grades
API specification number
DS.SP.Ph.Int.DHA-D version No. 1.1
Storage condition
Store in a refrigerator (2 °C to 8 °C)
Storage period (months)
60
Duration type
Shelf life
Packaging
Primary: LDPE bag tied with a plastic strip in a black LDPE Secondary: HDPE drum sealed with a plastic seal.
API Manufacturing Site(s)
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India