Product details
WHO Product ID
WHOAPI-243
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Neglected tropical diseases
Type
None
Grade
Standard
INN
Praziquantel
Confirmation of WHO API prequalification document (version date)
Applicant organization
Solara Active Pharma Sciences Limited
2nd Floor, Admin block 27 Vandaloor, Kelambakkram Road Keelakottaiyur Village, Melakottaiyur (Post)
Chennai,
Tamil Nadu
600 127
India
APIMF Version Number
Solara/WHO/Praziquantel/OP/001/November 2018
Solara/WHO/Praziquantel/RP/001/November 2018
Sequent/WHO/Praziquantel/RP/001/November, 2018 (Amendment-1, October 2023)
Sequent/WHO/Praziquantel/OP/001/November, 2018 (Amendment-1, October 2023)
Solara/WHO/Praziquantel/RP/001/November 2018
Sequent/WHO/Praziquantel/RP/001/November, 2018 (Amendment-1, October 2023)
Sequent/WHO/Praziquantel/OP/001/November, 2018 (Amendment-1, October 2023)
Product Grades
API specification number
1400001552_1101_FP3/FP/R3
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
White high molecular high density polyethylene (HM HDPE) bags placed into a black HMHDPE bags in high density polyethylene (HDPE) container.
API Manufacturing Site(s)
Solara Active Pharma Sciences Ltd
120 A & B, 36, 120P & 121 Industrial Area, Baikampady
New Mangalore,
Karnataka
575 011
India