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	300	mg	tablet
abacavir + lamivudine	60/30	mg	tablet
aciclovir	200	mg	tablet
aciclovir	400	mg	tablet
aciclovir	400	mg	tablet
amikacin	1000	mg	powder, injection
amikacin	500	mg	powder, injection
amodiaquine + artesunate	135/50	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	270/100	mg	tablet
amodiaquine + artesunate	67.5/25	mg	tablet
amodiaquine + artesunate	67.5/25	mg	tablet
amodiaquine + artesunate	67.5/25	mg	tablet
amoxicillin + clavulanate potassium	500/125	mg	tablet
amytriptyline	10	mg	tablet
amytriptyline	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
artemether + lumefantrine	20/120	mg	tablet
artemether + lumefantrine	40/240	mg	tablet
artemether + lumefantrine	80/480	mg	tablet
artesunate	120	mg	powder, injection
artesunate	30	mg	powder, injection
artesunate + pyrimethamine + sulfadoxine	100/25/500	mg	tablet
atazanavir	300	mg	capsule
atazanavir + ritonavir	300/100	mg	tablet
azithromycin	250	mg	tablet
azithromycin	250	mg	tablet
capreomycin	1	g	powder, injection
capreomycin	1	g	powder, injection
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
ciprofloxacin	250	mg	tablet
ciprofloxacin	250	mg	tablet
ciprofloxacin	500	mg	tablet
ciprofloxacin	500	mg	tablet
clarithromycin	250	mg	tablet
clarithromycin	250	mg	tablet
clarithromycin	500	mg	tablet
clarithromycin	500	mg	tablet
clindamycin	150	mg	capsule
clindamycin	300	mg	capsule
cycloserine	250	mg	capsule
cycloserine	250	mg	capsule
cycloserine	250	mg	capsule
cycloserine	250	mg	capsule
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
diethylcarbamazine citrate	100	mg	tablet
dihydroartemisinin + piperaquine	160/20	mg	tablet
dihydroartemisinin + piperaquine	320/40	mg	tablet
dihydroartemisinin + piperaquine	40/320	mg	tablet
efavirenz	600	mg	tablet
efavirenz + emtricitabine + tenofovir	600/200/300	mg	tablet
efavirenz + emtricitabine + tenofovir	600/200/300	mg	tablet
efavirenz + emtricitabine + tenofovir	600/200/300	mg	tablet
efavirenz + emtricitabine + tenofovir	600/200/300	mg	tablet
efavirenz + lamivudine + tenofovir	600/300/300	mg	tablet
emtricitabine + tenofovir	200/300	mg	tablet
emtricitabine + tenofovir	200/300	mg	tablet
emtricitabine + tenofovir	200/300	mg	tablet
emtricitabine + tenofovir	200/300	mg	tablet
emtricitabine + tenofovir	200/300 + 200	mg	tablet
ethambutol	100	mg	tablet
ethambutol	400	mg	tablet
ethambutol	400	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 + rifampicin	275/75/150	mg	tablet
ethinylestradiol + desogestrel	30/150	µg	tablet
ethinylestradiol + levonorgestrel + ferrous fumerate	30/150µg + 75	mg	tablet
ethinylestradiol + levonorgestrel + placebo	30/150 + 0	µg	tablet
etonogestrel	68	mg	implant
fluconazole	2	mg/ml	solution, injection
fluconazole	50	mg	tablet
fluoxetine	20	mg	capsule
ibuprofen	400	mg	soft capsule
isoniazid + rifampicin	150/300	mg	tablet
isoniazid + rifampicin	75/150	mg	tablet
kanamycin	1.0	g	powder, injection
kanamycin	500	mg	powder, injection
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 + nevirapine + zidovudine	30/50/60	mg	tablet for oral suspension
lamivudine + tenofovir	300/300	mg	tablet
lamivudine + zidovudine	150/300	mg	tablet
lamivudine + zidovudine	30/60	mg	tablet
lamivudine + zidovudine	30/60	mg	tablet for oral suspension
levofloxacin	250	mg	tablet
levofloxacin	250	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
levofloxacin	750	mg	tablet
levonorgestrel	0.75	mg	tablet
levonorgestrel	0.75	mg	tablet
levonorgestrel	1.5	mg	tablet
levonorgestrel	75	mg	implant
lopinavir + ritonavir	100/25	mg	tablet
lopinavir + ritonavir	133.30/33.30	mg	soft capsule
lopinavir + ritonavir	200/50	mg	tablet
lopinavir + ritonavir	80/20	mg	solution, oral
misoprostol	200	µg	tablet
misoprostol	200	µg	tablet
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	100	mg	tablet
nevirapine	20	mg	tablet
nevirapine	200	mg	tablet
nevirapine	50	mg	tablet
nevirapine	50	mg	tablet for oral suspension
nevirapine	50	mg	tablet for oral suspension
norethisterone enantate + estradiol valerate	50/5	mg/ml	solution, injection
ondansetron	2	mg/ml	solution, injection
ondansetron	4	mg	tablet
ondansetron	8	mg	tablet
oseltamivir	30	mg	capsule
oseltamivir	45	mg	capsule
oseltamivir	75	mg	capsule
prothionamide	250	mg	tablet
prothionamide	250	mg	tablet
pyrazinamide	400	mg	tablet
pyrimethamine + sulfadoxine + amodiaquine	500/25 + 150	mg	tablet
rifampicin	150	mg	capsule
ritonavir	100	mg	tablet
ritonavir	100	mg	tablet
streptomycin	1.0	g	powder, injection
sulfamethoxazole + trimethoprim	400/80	mg	tablet
sulfamethoxazole + trimethoprim	800/160	mg	tablet
tenofovir	300	mg	tablet
tenofovir	300	mg	tablet
tenofovir	300	mg	tablet
zidovudine	10	mg/ml	solution, oral
zidovudine	60	mg	tablet
zinc sulfate	20	mg	tablet
zinc sulfate	20	mg	tablet
zinc sulfate	20	mg	tablet