Product details
WHO Product ID
WHOAPI-341
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Neglected tropical diseases
Grade
Standard
INN
Praziquantel
Confirmation of WHO API prequalification document (version date)
Applicant organization
Alivira Animal Health Limited
Visakhapatnam, Plot No. 104 to 109 & Part of 112 & 113 JNPC-SEZ, Parawada Mandal
Visakhapatnam,
Andhra Pradesh
531 019
India
APIMF Version Number
Alivira/WHO/Praziquantel/OP/001/April 2017
Amendment – 1, November 2018
Amendment – 2, March 2019
Amendment – 3, July 2019
Alivira /WHO/Praziquantel/RP/001/April 2017
Amendment – 1, November 2018
Amendment – 2 March 2019
Amendment – 3, July 2019
Amendment – 1, November 2018
Amendment – 2, March 2019
Amendment – 3, July 2019
Alivira /WHO/Praziquantel/RP/001/April 2017
Amendment – 1, November 2018
Amendment – 2 March 2019
Amendment – 3, July 2019
Product Grades
API specification number
PRZF/02B/FP1/R8
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
White high molecular high density polyethylene (HM HDPE) bags, closed by non-releasable straps followed by black HM HDPE bags and closed by non releasable straps, placed in high density polyethylene (HDPE) drums.
API Manufacturing Site(s)
Alivira Animal Health Limited
Visakhapatnam, Plot No. 104 to 109 & Part of 112 & 113 JNPC-SEZ, Parawada Mandal
Visakhapatnam,
Andhra Pradesh
531 019
India