Product details
WHO Product ID
WHOAPI-424
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Protionamide
Confirmation of WHO API prequalification document (version date)
Applicant organization
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
APIMF Version Number
MLL/Protionamide/OP-00/February-2021
MLL/Protionamide/RP-00/ February-2021
Response 9th December 2021
Response 23rd August 2022
Response 27th September 2022
MLL/Protionamide/RP-00/ February-2021
Response 9th December 2021
Response 23rd August 2022
Response 27th September 2022
Product Grades
API specification number
FPSPP1221, Revision 07
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Primary packaging: Transparent polythene bag
Secondary packaging: Black polyethylene bag
Tertiary packaging: HDPE container.
Secondary packaging: Black polyethylene bag
Tertiary packaging: HDPE container.
API Manufacturing Site(s)
Micro Labs Ltd
API - Division (ML-15), Plot No.43-45, KIADB, Jigani-Bommasandra Link Road, Anekal Taluk
Bengaluru,
Karnataka
560 105
India