New Product Status Existing product status

Unit Line Ratio of Status

Maximum daily dose Ratio of BS to Maximum daily dose
Product Name Batch size (BS) Product Name Batch size (BS) kg BS to
(MDD) MDD (MDD)
MDD
Imegli 500 Tab 28 1440.32 19440.1244167963 Leptic ODT 0.25 50 8000 6250 Not change

Olic 5 tablet 4.68 265.43 17631.7673209509 Leptic ODT 0.25 50 8000 6250 Not change

Olic 10 Tablet 1.17 132.51 8829.52230020376 Leptic ODT 0.25 50 8000 6250 Not change

Omari 12.5 tablet 1.435 802.63 1787.87236958499 Leptic ODT 0.25 50 8000 6250 Omari 12.5 tablet

Omari 25 tablet 2.46 449.4 5473.9652870494 Leptic ODT 0.25 50 8000 6250 Omari 25 tablet

BLS Tablet M-Gaba 2.5 Tablet 7.8 514 15175.0972762646 Leptic ODT 0.25 50 8000 6250 Not change

M-Gaba 5 Tablet 19.5 257 75875.486381323 Leptic ODT 0.25 50 8000 6250 Not change

M-Gaba 10 Tablet 7.8 256 30468.75 Leptic ODT 0.25 50 8000 6250 Not change

Glifo-M 12.5/500 26.55 2393 11094.8600083577 Leptic ODT 0.25 50 8000 6250 Not change

Glifo-M 25/1000 25.74 1219.61 21105.1073703889 Leptic ODT 0.25 50 8000 6250 Not change

Prindol 3 Tablet 26 779.22 33366.7000333667 Leptic ODT 0.25 50 8000 6250 Not change

Maco limit with of previous product (worst case next product) and new worst case next prodcut

LDTD × WC LDTD × BS 3 mg.day-1 × 50 Kg

MACO(Dose) = = = = 18.75 mg
SF SF×MDD 1000×8000 mg
t
le
ab Where,
lT
ni LDTD = Lowest Daily Therapeutic Dose of Bromazepam = 3 mg.day-1 = 1.79 mg
Te SF = Safety Factor = 1000 (Oral Dosage Form) 1000×802.63 mg
BS= Batch Size of Next Product, Leptic ODT 0.25 Tablet (Clonazepam) = 50.00 kg BS= Batch Size of Next Product, Omari 12.5 tablet = 1.435 kg

MDD=Maximum Daily Dose (Leptic ODT 0.25 Tablet) = 8000 mg.day-1 MDD=Maximum Daily Dose (Leptic
3 mg.day
ODT
-1
×0.25
1.435
Tablet)
Kg =802.63 mg.day-1

PDE × WC PDE × BS 0.006 mg.day-1 x 50 kg

MACO(PDE) = = = = 37.50 mg
MDD MDD 8000 mg.day-1
et
bl Where,
Ta
40 0.006 mg.day-1 × 1.435 =
5/ PDE= Permitted Daily Exposure of Olmesartan Medoxomil = 0.006 mg.day-1mg.day-1
Kg 10.73 mg
n
pi
ba 802.63 mg
Or BS= Batch Size of Next Product, Leptic ODT 0.25 Tablet (Clonazepam) = 50.00 kg BS= Batch Size of Next Product, Omari 12.5 tablet = 1.435 kg
MDD=Maximum Daily Dose (Leptic ODT 0.25 Tablet) = 8000 mg.day-1 MDD=Maximum Daily Dose (Leptic ODT 0.25 Tablet) =802.63 mg.day-1

PDE × WC PDE × BS 0.03mg.day-1 x 50 kg

MACO(PDE) = = = = 187.5 mg
MDD MDD 8000 mg.day-1
t
b le
Ta
ax
M
-A
th
Ar
 Where,

PDE= Permitted Daily Exposure of Diacerein = 0.03 mg.day- 0.03 mg.day-1 × 1.435 Kg =
53.64 mg
802.63 mg
BS= Batch Size of Next Product, Leptic ODT 0.25 Tablet (Clonazepam) = 50.00 kg BS= Batch Size of Next Product, Omari 12.5 tablet = 1.435 kg
MDD=Maximum Daily Dose (Leptic ODT 0.25 Tablet) = 8000 mg.day-1 MDD=Maximum Daily Dose (Leptic ODT 0.25 Tablet) =802.63 mg.day-1

MACO10 ppm = 10ppm × BS = 10 ppm× 50 kg

MACO(PPM) = = 500 mg
et
bl =
Ta 10 ppm× 1.435 kg = 14.35 mg
20
l1
ni
A la
BS= Batch Size of Next Product, Leptic ODT 0.25 Tablet (Clonazepam) = 50.00 kg BS= Batch Size of Next Product, Omari 12.5 tablet = 1.435 kg
MDD=Maximum Daily Dose (Leptic ODT 0.25 Tablet) = 8000 mg.day-1 MDD=Maximum Daily Dose (Leptic ODT 0.25 Tablet) =802.63 mg.day-1