Status of PQ Applicant dossiers

This sheet

provides information on the status of submitted - not yet prequalified - dossiers;
only includes dossiers that have been screened and accepted into assessment;
includes several products with the same INN, strength, unit and dosage form. In such cases, the manufacturers differ;
does not include inspection data at present. Such data are essential to be able to determine how close a product is to prequalification. For example, in cases where both dossier parts have been accepted, there may still be outstanding issues with respect to the manufacturing sites involved. Inspection data will be added as soon as possible;
does not include prequalified products. Once a product is prequalified, it is included in a separate list of prequalified products (see links on the front page of the Prequalification Programme website).

assessment in progress

additional data to be provided by the manufacturer

dossier part acceptable

Product (INNs)	Strength	Unit	Dosage Form
abacavir	20	mg/ml	solution, oral
abacavir + lamivudine	60/30	mg	tablet
amodiaquine + artesunate	135/50	mg	tablet
amodiaquine + artesunate	135/50	mg	tablet
amodiaquine + artesunate	270/100	mg	tablet
amodiaquine + artesunate	270/100	mg	tablet
amodiaquine + artesunate	67.5/25	mg	tablet
amodiaquine + artesunate	67.5/25	mg	tablet
artemether	80	mg/ml	solution, injection
artemether	80	mg/ml	solution, injection
artemether + lumefantrine	20/120	mg	tablet
artemether + lumefantrine	20/120	mg	tablet
artemether + lumefantrine	20/120	mg	tablet
artesunate	120	mg	powder, injection
artesunate	30	mg	powder, injection
artesunate + mefloquine	100/200	mg	tablet
artesunate + mefloquine	25/50	mg	tablet
artesunate + pyrimethamine + sulfadoxine	100/25/500	mg	tablet
capreomycin	1	g	powder, injection
capreomycin	1	g	powder, injection
capreomycin	1.0	g	powder, injection
ceftriaxone	1.0	g	powder, injection
ceftriaxone	500	mg	powder, injection
cycloserine	250	mg	capsule
cycloserine	250	mg	capsule
cycloserine	250	mg	capsule
cycloserine	250	mg	capsule
darunavir	150	mg	tablet
darunavir	600	mg	tablet
darunavir	75	mg	tablet
didanosine	100	mg	tablet
didanosine	25	mg	tablet
didanosine	250	mg	capsule
didanosine	400	mg	capsule
didanosine	50	mg	tablet
diethylcarbamazine citrate	100	mg	tablet
dihydroartemisinin + piperaquine	40/320	mg	tablet
efavirenz	600	mg	tablet
efavirenz	600	mg	tablet
efavirenz + emtricitabine + tenofovir	600/200/300	mg	tablet
efavirenz + emtricitabine + tenofovir	600/200/300	mg	tablet
emtricitabine + tenofovir	200/300	mg	tablet
ethambutol	100	mg	tablet
ethambutol	100	mg	tablet
ethambutol	400	mg	tablet
ethambutol	400	mg	tablet
ethambutol	400	mg	tablet
ethambutol + isoniazid	400/150	mg	tablet
ethambutol + isoniazid	400/150	mg	tablet
ethambutol + isoniazid + pyrazinamide + rifampicin	275/75/400/150	mg	tablet
ethambutol + isoniazid + pyrazinamide + rifampicin	275/75/400/150	mg	tablet
ethambutol + isoniazid + pyrazinamide + rifampicin	275/75/400/150	mg	tablet
ethambutol + isoniazid + rifampicin	275/75/150	mg	tablet
ethambutol + isoniazid + rifampicin	275/75/150	mg	tablet
ethambutol + isoniazid + rifampicin	275/75/150	mg	tablet
ethinylestradiol + levonorgestrel	0.15/0.03	mg	tablet
ethinylestradiol + levonorgestrel	30/150	µg	tablet
ethinylestradiol + levonorgestrel + placebo	0.15/0.03	mg	tablet
ethionamide	250	mg	tablet
ethionamide	250	mg	tablet
etravirine	100	mg	tablet
ganciclovir	500	mg	powder, injection
ibuprofen	400	mg	soft capsule
isoniazid	100	mg	tablet
isoniazid + pyrazinamide + rifampicin	30/150/60	mg	tablet
isoniazid + rifampicin	150/150	mg	tablet
isoniazid + rifampicin	150/300	mg	tablet
isoniazid + rifampicin	30/60	mg	tablet
isoniazid + rifampicin	75/150	mg	tablet
isoniazid + rifampicin	75/150	mg	tablet
kanamycin	1.0	g	powder, injection
kanamycin	500	mg	powder, injection
lamivudine	10	mg/ml	solution, oral
lamivudine	150	mg	tablet
lamivudine	30	mg	tablet
lamivudine	30	mg	tablet
lamivudine	30	mg	tablet
lamivudine + nevirapine + tenofovir	300+200+300	mg	tablet
lamivudine + nevirapine + zidovudine	150/200/300	mg	tablet
lamivudine + nevirapine + zidovudine	30/50/60	mg	tablet for oral suspension
lamivudine + tenofovir	300/300	mg	tablet
lamivudine + tenofovir	300/300	mg	tablet
lamivudine + zidovudine	150/300	mg	tablet
levofloxacin	250	mg	tablet
levofloxacin	250	mg	tablet
levofloxacin	250	mg	tablet
levofloxacin	500	mg	tablet
levofloxacin	500	mg	tablet
levofloxacin	500	mg	tablet
levonorgestrel	0.75	mg	tablet
levonorgestrel	1.5	mg	tablet
levonorgestrel	75	mg	implant
lopinavir + ritonavir	133.30/33.30	mg	soft capsule
lopinavir + ritonavir	200/50	mg	tablet
lopinavir + ritonavir	80/20	mg	solution, oral
moxifloxacin	400	mg	tablet
moxifloxacin	400	mg	tablet
moxifloxacin	400	mg	tablet
moxifloxacin	400	mg	tablet
nevirapine	100	mg	tablet for oral suspension
nevirapine	100	mg	tablet for oral suspension
nevirapine	50	mg	tablet for oral suspension
nevirapine	50	mg	tablet for oral suspension
norethisterone enantate + estradiol valerate	50/5	mg/ml	solution, injection
ofloxacin	200	mg	tablet
ofloxacin	200	mg	tablet
ofloxacin	400	mg	tablet
ofloxacin	400	mg	tablet
oxytocin	10	IU/ml	solution, injection
oxytocin	10	IU/ml	solution, injection
prothionamide	250	mg	tablet
prothionamide	250	mg	tablet
prothionamide	250	mg	tablet
pyrazinamide	500	mg	tablet
rifampicin	150	mg	capsule
rifampicin	300	mg	capsule
streptomycin	1.0	g	powder, injection
tenofovir	300	mg	tablet
tenofovir	300	mg	tablet
tenofovir	300	mg	tablet
zidovudine	10	mg/ml	solution, oral
zidovudine	10	mg/ml	solution, oral
zidovudine	60	mg	tablet for oral suspension
zidovudine	60	mg	tablet
zinc sulfate	20	mg	tablet
zinc sulfate	20	mg	tablet
zinc sulfate	20	mg	tablet for oral suspension
zinc sulfate	20	mg	tablet