Product details
WHO Product ID
WHOAPI-204
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Tenofovir disoproxil fumarate
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/TDF/OP-2020/00
MDOL/TDF/RP-2020/00
MDOL/TDF/OP-2020/01
MDOL/TDF/RP-2020/01
MDOL/TDF/RP-2020/00
MDOL/TDF/OP-2020/01
MDOL/TDF/RP-2020/01
Product Grades
API specification number
DS.SP.IH.TFD-D, Version No. 1.1
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Shelf life
Packaging
Colorless LDPE bag, inserted in black LDPE bag. LDPE bags are kept in HDPE drum.
API Manufacturing Site(s)
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India