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WHOAPI-139: Emtricitabine

Product details
WHO Product ID
WHOAPI-139
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Emtricitabine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Laurus Labs Limited
2nd Floor, Serene Chambers, Road No. 7, Banjara Hills
Hyderabad,
Telangana
500 034
India
APIMF Version Number
LL/EMTRICITABINE/OP/02/AUGUST-2018
LL/EMTRICITABINE/RP/02/AUGUST-2018
LL/EMTRICITABINE/OP/02/AUGUST-2018/Amend-1/February-2019
LL/EMTRICITABINE/RP/02/AUGUST-2018/Amend-1/February-2019
LL/EMTRICITABINE/OP/02/AUGUST-2018/Amend-2/August-2021
LL/EMTRICITABINE/RP/02/AUGUST-2018/Amend-2/August-2021
LL/EMTRICITABINE/OP/02/AUGUST-2018/Amend-3/April-2022
LL/EMTRICITABINE/RP/02/AUGUST-2018/Amend-3/April-2022
LL/EMTRICITABINE/OP/02/AUGUST-2018/Amend-4/December-2022
LL/EMTRICITABINE/RP/02/AUGUST-2018/Amend-4/December-2022
LL/EMTRICITABINE/OP/02/AUGUST-2018/Amend-5/April-2023
LL/EMTRICITABINE/RP/02/AUGUST-2018/Amend-5/April-2023
LL/EMTRICITABINE/OP/02/AUGUST-2018/ mend-6/July-2024
LL/EMTRICITABINE/RP/02/AUGUST-2018/ mend-6/July-2024
LL/EMTRICITABINE/RP/02/AUGUST-2018/Amend-7/Sept-2024
Product Grades
API specification number
FS/AECB/02 version 9
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
48
Duration type
Retest period
Packaging
Double transparent LDPE bags housed within HDPE drums
API Manufacturing Site(s)
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India

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