Product details
WHO Product ID
WHOAPI-431
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Neglected tropical diseases
Type
None
Grade
Standard
INN
Albendazole
Confirmation of WHO API prequalification document (version date)
Applicant organization
Rakshit Drugs Private Limited
425/3RT, Door no. 7-1-621/328, Hyderabad
Sanjeev Reddy Nagar,
Telangana
500038
India
APIMF Version Number
ALBENDAZOLE/OP/00/July-2021
ALBENDAZOLE/RP/00/July-2021
Response dated 5.7.2022
Response dated 24.1.2024
Response dated 27.1.2025
Response dated 11.12.2025
ALBENDAZOLE/RP/00/July-2021
Response dated 5.7.2022
Response dated 24.1.2024
Response dated 27.1.2025
Response dated 11.12.2025
Product Grades
API specification number
STP/S/FP/6002/005-5
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Primary Packaging: A transparent low-density polythene (LDPE) primary bag, tied with nylon strip
Secondary Packaging: A black low-density polythene bag (LDPE) tied with nylon strip. Black LDPE bag is placed in triple laminated aluminum bag and seal with heat and finally placed in High-density polythene drums with clamp (HDPE).
Secondary Packaging: A black low-density polythene bag (LDPE) tied with nylon strip. Black LDPE bag is placed in triple laminated aluminum bag and seal with heat and finally placed in High-density polythene drums with clamp (HDPE).
API Manufacturing Site(s)
Rakshit Drugs Private Limited
Unit III Plot 4 J.N. Pharma City Parawada, Anakapalli Dist
Thadi,
Andhra Pradesh
531021
India