Apr 78

Annual Product Review (APR)
(F.Y. 78/79)
Product Name: Vaslod-2.5 Tablets
Manufacturing Time (min) Uniformity of content(%) Dissolution (D)% Assay

Average Thickness Diameter
Batch No: (Amlodipine
Sifting Mixing Lubrication Wt. (mg) Min Max (mm) (mm) Min Max Besylate)
8001 35 20 10 103.8 103.90% 110.70% 3 6.39 108.60% 116.50% 108.10%
(F.Y. 78/79)
Product Name: Vaslod-5 Tablets

8010 30 30 10 103.5 96.10% 106.20% 2.98 6.43 101.90% 110.70% 103.90%
8011 40 30 10 101.9 98.10% 102.30% 2.98 6.41 102.30% 106.50% 103.80%
Manufacturing Time
45
40
40
35
30 30 30
30
25
Min
20
15
10 10
10
5
0
Sifting Mixing Lubrication
8010 8011
Average Wt.
104
103.5
103.5
103
102.5
mg
102 101.9
101.5
101
1 2
Uniformity of Content
108.00%
106.20%
106.00%
104.00%
102.30%
102.00%
100.00%
98.10%
(%)
98.00%
96.10%
96.00%
94.00%
92.00%
90.00%
Min Max
8010 8011
98.00%
(
96.10%
96.00%
94.00%
92.00%
90.00%
Min Max
8010 8011
Thickness
3.5
2.98 2.98
3
2.5
2
mm
1.5
0.5
0
1 2
Diameter
6.435
6.43
6.43
6.425
6.42
mm
6.415
6.41
6.41
6.405
6.4
1 2
m
6.415
6.41
6.41
6.405
6.4
1 2
Dissolution (D)
112.00% 110.70%
110.00%
108.00%
(%)
106.50%
106.00%
104.00%
101.90% 102.30%
102.00%
100.00%
98.00%
96.00%
Min Max
8010 8011
Assay
103.92%
103.90%
103.90%
103.88%
103.86%
103.84%
(%)
103.82%
103.80%
103.80%
103.78%
103.76%
103.74%
1 2
103.86%
103.84%
(%)
103.82%
103.80%
103.80%
103.78%
103.76%
103.74%
1 2
(F.Y. 78/79)
Product Name: Vaslod-10 Tablets

8016 130 30 10 105.4 97.10% 103.50% 2.99 6.41 105.70% 112.10% 106.30%
(F.Y. 78/79)
Product Name: Vaslod-AT Tablets
Manufacturing Time (min) Uniformity of content(%) Dissolution % (D) Assay
Sifting &
Batch Sifting of Preparation Mixing of Average Wt. Thickness Diameter
mixing of Amlodipine Besilate Atenolol
No: Atenolol of Atenolol & (mg) (mm) (mm) Amlodipine
Mixing Granulation Amlodipine Lubrication Min Max Atenolol
with Granulating Amlodipine Besilate
with
excepients solution Besilate
excepints
Min Max Min Max
8002 30 30 50 10 35 30 10 305.6 94.9 104.3 4.25 9.08 97.00% 101.3% 100.6% 103.8% 105.40% 106.70%
8044 55 20 60 30 30 20 10 308.9 97.5 104.7 4.19 9.06 89.40% 92.9% 109.4% 110.3% 106.10% 105.20%
8100 140 20 30 5 60 15 5 302.7 95.6 104.1 4.23 9.06 89.80% 120.9% 74.9% 101.4% 97.70% 103.50%
Manufacturing Time
160 140
120
80 55 50 60 60
30 30 20 20 30 30 35 30 30 20
40 10 15 10 10 5
5
0
g n n s n
en
ts in tio io nt ate tio
pi ix u lat pi sil ica
M ol nu ce Be
ce br
(min)
s ex
ex g ra ne Lu
in G ith pi
ith lat w di
l w nu in
e lo
lo ra ip m
o G d A
ten n
of m
lo l &
A lo
of tio A o
ng ra of ten
fti pa in
g A
Si P re ix of
m g
& in
g ix
in M
S ift
8002 8044 8100
Average Wt.
310
308.9
308
306 305.6
304
302.7
302
300
298
1 2 3
106
104.3 104.7
104.1
104
102
100
98 97.5
96 95.6
94.9
94
92
90
1 2 3
min max
Thickness
4.26
4.25
4.25
4.24
4.23
4.23
4.22
(mm)
4.21
4.2
4.19
4.19
4.18
4.17
4.16
1 2 3
Diameter
9.085
9.08
9.08
(mm)
9.075
9.07
9.065
9.06 9.06
9.06
9.055
9.05
1 2 3
Diameter
9.085
9.08
9.08
(mm)
9.075
9.07
9.065
9.06 9.06
9.06
9.055
9.05
1 2 3
Dissolution (D)
140.00%
120.9% 103.8% 101.4%
120.00% 89.40%
109.4% 110.3%
97.00% 101.3% 100.6%
100.00% 89.80% 92.9%
74.9%
80.00%
60.00%
40.00%
20.00%
0.00%
Max
Atenolol Min
Max
Amlodipine Besilate Min
8002 8044 8100
Assay
108.00% 106.70%
106.10%
106.00% 105.40% 105.20%
104.00% 103.50%
102.00%
100.00%
97.70%
98.00%
96.00%
94.00%
92.00%
1 2 3
Amlodipine Losartan Potassium

(F.Y. 78/79)
Product Name: Vaslod L Tablets
Manufacturing Time (min) Uniformity of content(%) Dissolution % (D) Assay

Sifting of Sifting & Mixing of
Batch Losartan Preparation Sifting of mixing of Losartan Average Thickness Diameter
No: Losartan
potassium Mixing of binder Granulation Drying dried Amlodipine Potassium & Lubrication Wt. (mg) Min Max (mm) (mm) Amlodipine
Min Max Min Max Potassium
with solution granules with Amlodipine
excepients excepints Besylate
8019 30 30 50 20 30 30 30 30 10 218.6 98.2 105 4.12 8.26 94.20% 97.1% 99.6% 105.90% 102.20% 103.00%
8047 50 25 60 15 390 30 60 30 10 216.3 97.5 101.3 4.09 8.26 89.70% 92.80% 103.80% 107.40% 104.50% 103.90%
8119 150 30 30 10 60 80 30 20 10 221.3 97.6 102.8 4.1 8.29 75.40% 88.70% 100.10% 103.60% 97.70% 103.80%
Manufacturing Time
390
400
300
200 150
50 60 30 60 80 60
100 30 50 30 25 30 20 15 10 30 30 30 30 30 30 30 20 10 10 10
0
en
ts
xi
ng tio
n
io
n
in
g les nt
s
lat
e
tio
n
pi i u lat ry nu pi sy ica
M ol nu D ra ce br
ce rs ra g ex Be
ex de G ied ith ne Lu
ith in dr w pi
w fb of ne di
m o pi lo
iu tio
n ng di m
tas
s
ra fti lo A
pa Si m &
po re A m
rta
n P of s iu
sa in
g tas
Lo ix Po
of m tan
g & ar
tin ng os
Si
f fti fL
Si o
g
in
ix
8019 8047 8119
M
Average Wt.
222
221.3
221
220
219 218.6
218
217
216.3
216
215
214
213
1 2 3
106 105
104
102.8
102 101.3
100
98.2
98 97.5 97.6
96
94
92
1 2 3
Min Max
Thickness
4.125
4.12
4.12
4.115
4.11
4.105
4.1
4.1
4.095
4.09
4.09
4.085
4.08
4.075
4.07
1 2 3
Diameter
8.295
8.29
8.29
8.285
8.28
8.275
8.27
8.265
8.26 8.26
8.26
8.255
8.25
8.245
1 2 3
8.27
8.265
8.26 8.26
8.26
8.255
8.25
8.245
1 2 3
Dissolution
120.00%
107.40%
105.90%
103.80% 103.60%
97.1% 99.6% 100.10%
100.00% 94.20% 92.80%
89.70% 88.70%
80.00% 75.40%
60.00%
40.00%
20.00%
0.00%
Max
Losartan Potassium Min
Max
Amlodipine Min
8019 8047 8119
Assay
106.00%
104.50%
103.90% 103.80%
104.00%
103.00%
102.20%
102.00%
100.00%
98.00% 97.70%
96.00%
94.00%
1 2 3

(F.Y. 78/79)
Product Name: Lulirex Cream (30g)
Mixing time(min)
Before After Assay
Batch No: pH Avg.wt. (g)
addition of addition of (Luliconzole)
API API
8003 95 145 6.4 30.07 108.50%
8030 60 150 6.18 30.44 107.50%
8031 55 170 6.15 30.05 107.10%
Mixing time
180 170
160 150
145
140
120
100 95
Min
80
60 55
60
40
20
0
1 2 3
pH
6.45
6.4
6.4
6.35
6.3
6.25
6.2 6.18
6.15
6.15
6.1
6.05
6
1 2 3
6.1
6.05
6
1 2 3
Avg.wt.
30.5
30.44
30.4
30.3
30.2
30.1 30.07
30.05
30
29.9
29.8
1 2 3
Assay
109.00%
108.50%
108.50%
108.00%
107.50%
107.50%
107.10%
107.00%
106.50%
106.00%
1 2 3
(F.Y. 78/79)
Product Name: Lulirex Cream (15g)
Mixing time(min)
Before After Avg.wt. Assay
Batch No: pH
addition of addition of (g) (Luliconazole)
API API
8033 45 140 6.12 15.10 106.60%
(F.Y.78/79)
Product Name: Dimeli-1 Tablets
Manufacturing Time (min) Uniformity of content(%) Dissolution (D)%

Average Friability Hardness Thickness Diameter Assay
Batch No: DT
Sifting Mixing Lubrication Wt. (mg) (%w/w) Min Max (kg/cm2) (mm) (mm) Min Max (Glimepiride)
8004 35 20 20 101.1 4 min 32 sec 0.13 104.90% 114.10% 3 2.94 6.42 88% 91.20% 105.20%
(F.Y.78/79)
Product Name: Dimeli-2 Tablets

Average Friability Hardness Thickness Diameter Assay
Batch No: DT
Sifting Mixing Lubrication Wt. (mg) (%w/w) Min Max (kg/cm2) (mm) (mm) Min Max (Glimepiride)
8009 60 30 10 126 4 min 35 sec 0.08 107.10% 110.40% 4 3.47 6.37 82% 91.50% 105.20%
(F.Y. 78/79)
Product Name: Zoom-200 Suspension (30ml)
Mixing time (min)

Avg. fill Weight
Before After Assay
Batch No: pH volume per ml
addition of addition of (Azithromycin)
(ml) (g)
API API
8006 210 190 10.86 30.15 1.11 108.20%
8015 260 205 10.32 31.3 1.1 107.50%
8032 210 180 10.6 30.3 1.11 107.90%
8043 135 355 10.49 30.5 1.11 108.50%
8106 355 130 9.26 31.8 1.1 104.70%
Mixing time
400
355 355
350
300
(min)
260
250
210 205 210
190 180
200
150 135 130
100
50
0
1 2 3 4 5
Before addition of API After addition of API
pH
11.5
11 10.86
10.6
10.49
10.5 10.32
10
9.5 9.26
8.5
8
1 2 3 4 5
8.5
8
1 2 3 4 5
Avg. fill volume

32 31.8
31.5 31.3
31
30.5
30.5
(ml)
30.3
30.15
30
29.5
29
1 2 3 4 5
Weight per ml
1.112
1.11 1.11 1.11
1.11
1.108
1.106
1.104
1.102
1.1 1.1
1.1
1.098
1.096
1.094
1 2 3 4 5
Assay
109.00% 108.50%
108.20%
107.90%
108.00% 107.50%
107.00%
106.00%
105.00% 104.70%
104.00%
103.00%
102.00%
1 2 3 4 5
105.00% 104.70%
104.00%
103.00%
102.00%
1 2 3 4 5
(F.Y. 78/79)
Product Name: Lincin Gel (15g)
Mixing time(min)
Assay
Before After Avg.wt.
Batch No: pH (Clindamycin
addition of addition of (g)
Phosphate)
API API
8012 240 165 5.5 15.03 104.70%
(F.Y. 78/79)
Product Name: Lincin-A gel (15g)
Mixing time(min) Assay

Batch No: pH Clindamycin
addition of addition of (g) Adapalene
Phosphate
API API
8072 200 90 5.94 15.21 106.40% 105.20%
(F.Y. 78/79)
Product Name: Acocin Ointment (15g)
Mixing time(min)
Batch No: pH
addition of addition of (g) (Mupirocin)
API API
8013 360 95 4.28 15.11 100.80%
8014 180 225 4.26 15.07 100.60%
8075 170 150 4.3 15.23 98.80%
8076 245 165 4.36 15.15 105.40%
8097 360 130 4.19 15.05 107.50%
8118 210 65 4.03 15.01 105.80%
Mixing Time
400
360 360
350
300
245
250 225
(min)
210
200 180 170 165
150
150 130
95
100 65
50
0
1 2 3 4 5 6
pH
4.4 4.36
4.3
4.3 4.28
4.26
4.19
4.2
4.1
4.03
4
3.9
3.8
1 2 3 4 5 6
3.9
3.8
1 2 3 4 5 6
Avg.wt.
15.25 15.23
15.2
15.15
15.15
15.11
15.1 15.07
15.05
15.05
15.01
15
14.95
14.9
14.85
1 2 3 4 5 6
Assay
110.00%
108.00% 107.50%
105.40% 105.80%
106.00%
104.00%
102.00% 100.80% 100.60%

100.00% 98.80%
98.00%
96.00%
94.00%
1 2 3 4 5 6
(F.Y. 78/79)
Product Name: Acocin Ointment (5g)
Mixing time(min)
Batch Before After Avg.wt. Assay
pH
No: addition of addition of (g) (Mupirocin)
API API
8095 290 130 4.25 5.023 102.20%
(F.Y. 78/79)
Product Name: Fevmol Suspension (60ml)
Mixing time (min)

Avg. fill
Before After Weight Assay
Batch No: pH volume
addition of addition of per ml (g) (Paracetamol)
(ml)
API API
8017 315 150 4.99 60.5 1.16 101.30%
8018 330 165 4.9 60.5 1.16 98.50%
8039 180 75 5.8 60.5 1.19 97.40%
8071 465 265 5.86 62.3 1.19 99.60%
8080 240 90 5.56 60.5 1.03 107.50%
8115 300 120 5.8 60.6 1.19 101.00%
Mixing Time
500 465
450
400
350 315 330
300
300 265
240
(min)
250
200 165 180
150
150 120
75 90
100
50
0
1 2 3 4 5 6
pH
6
5.86
5.8 5.8
5.8
5.6 5.56
5.4
5.2
4.99
5 4.9
4.8
4.6
4.4
1 2 3 4 5 6
4.8
4.6
4.4
1 2 3 4 5 6
Avg. fill volume

62.5 62.3
62
61.5
61
(ml)
60.6
60.5 60.5 60.5 60.5
60.5
60
59.5
1 2 3 4 5 6
Weight per ml
1.25
1.2 1.19 1.19 1.19

1.16 1.16
1.15
1.1
1.05 1.03
0.95
1 2 3 4 5 6
Assay
110.00%
108.00% 107.50%
106.00%
104.00%
102.00% 101.30% 101.00%
99.60%
100.00%
98.50%
98.00% 97.40%
96.00%
94.00%
92.00%
1 2 3 4 5 6
98.50%
98.00% 97.40%
96.00%
94.00%
92.00%
1 2 3 4 5 6
(F.Y. 78/79)
Product Name: Fevmol Plus Suspension (60ml)
Mixing time (min) Assay

Avg. fill Weight
Batch No: Before After pH volume per ml
addition of addition of (ml) (g) Paracetamol Ibuprofen
API API
8057 215 210 5.91 61 1.13 103.70% 102.80%
8077 305 150 5.83 61.8 1.13 98.80% 103.20%
8078 310 120 5.82 60.5 1.13 102.90% 100.10%
8079 330 150 5.78 61.7 1.12 99.70% 103.40%
8096 420 120 5.79 60.5 1.11 102.30% 104.60%
8116 360 140 5.85 60.4 1.13 102% 98.40%
8120 440 130 5.67 60.9 1.12 101.70% 98.50%
MIxing time
500
440
450 420
400 360
350 330
305 310
300
250 215 210
200
150 150 140
150 120 120 130
100
50
0
1 2 3 4 5 6 7
pH
5.95
5.91
5.9
5.85
5.85 5.83 5.82
5.78 5.79
5.8
5.75
5.7 5.67
5.65
5.6
5.55
5.5
1 2 3 4 5 6 7
Avg. fill volume
62 61.8
61.7
61.5
61
61 60.9
60.5 60.5
60.5 60.4
60
59.5
1 2 3 4 5 6 7
Weight per ml
1.135
1.13 1.13 1.13 1.13
1.13
1.125
1.12 1.12
1.12
1.115
1.11
1.11
1.105
1.1
1 2 3 4 5 6 7
Assay
106.00%
104.60%
103.70% 103.40%
104.00% 103.20% 102.90%
102.80%
102.30% 102% 101.70%
102.00%
100.10%
99.70%
100.00%
98.80% 98.40% 98.50%
98.00%
96.00%
94.00%
1 2 3 4 5 6 7
Paracetamol Ibuprofen
96.00%
94.00%
1 2 3 4 5 6 7
Paracetamol Ibuprofen
(F.Y. 78/79)
Product Name: Metfix-500 Tablets
Manufacturing Time (min)

Preparation Average Thickness Diameter Hardness
Batch No: of
Milling Sifting Granulation Drying Lubrication Wt. (mg) (mm) (mm) (Kg/cm2)
Granulating
solution
8037 140 85 120 20 100 20 600.6 4.06 12.8 6.4
8040 120 105 50 20 80 20 599.2 4.06 12.8 7.3
8102 150 115 50 70 60 20 605.1 4.19 12.8 11.2
Manufacturing Time
160 140 150
120 120
120 105115 100
85 80
70 60
80 50 50
40 20 20 20 20 20
0
in
g ng tio
n
io
n
in
g
tio
n
ill fti lat ry
M Si s o lu
n u D rica
g ra b
in G Lu
lat
anu
r
G
of
n
tio
ara
ep
Pr
8037 8040 8102
Average wt.
606
605.1
605
604
603
602
601 600.6
600 599.2
599
598
597
596
1 2 3
Thickness
4.25
4.2
4.15
4.1
4.05
3.95
1 2 3
4.05
3.95
1 2 3
Diameter
14
12.8 12.8 12.8
12
10
0
1 2 3
Hardness
12
11.2
10
8 7.3
6.4
6
0
1 2 3
Friability
0.35 0.33
0.3
0.25 0.23
0.21
0.2
0.15
0.1
0.05
0
1 2 3
0.15
0.1
0.05
0
1 2 3
Dissolution
140.00%
124.10%
120.00% 115.20%
103.40% 104.30% 105.80%
99.90%
100.00%
80.00%
60.00%
40.00%
20.00%
0.00%
1 2 3
Min Max
Assay
102.00%
101.50%
101.00%
100.10%
100.00%
99.00%
98.40%
98.00%
97.00%
96.00%
1 2 3
Dissolution (D)%
Assay
Friability
(Metformin
(% w/w) Min Max HCL)
0.21 103.40% 124.10% 98.40%

0.23 104.30% 115.20% 101.50%
0.33 99.90% 105.80% 100.10%
(F.Y. 78/79)
Product Name: Metfix-850 Tablets
Manufacturing Time (min) Dissolution (D)%

Preparation Assay
Batch Average Thickness Length Hardness Friability
of (Metformin
No: Milling Sifting Granulation Drying Lubrication Wt. (mg) (mm) (mm) (Kg/cm2) (% w/w) Min Max
Granulating HCL)
solution
8038 290 385 90 30 300 20 1029.2 5.85 20.52 16 0.11 97.80% 100.30% 98.50%
8041 155 120 60 30 330 20 1028.4 5.84 20.45 15.4 0.12 98.70% 102.10% 99.30%
Manufacturing Time
450
400 385
350 330
290 300
300
250
200 155
150 120
90
100
Min
60
50 30 30 20 20
0
8038 8041
Average Wt.
1029.4
1029.2
1029.2
1029
1028.8
mg
1028.6
1028.4
1028.4
1028.2
1028
1 2
1028.4
1028.4
1028.2
1028
1 2
Thickness
5.852
5.85
5.85
5.848
5.846
(mm)
5.844
5.842
5.84
5.84
5.838
5.836
5.834
1 2
Length
20.54
20.52
20.52
20.5
20.48
mm
20.46
20.45
20.44
20.42
20.4
1 2
Hardness
16.1
16
16
15.9
15.8
15.7
(Kg/cm2)
15.6
15.5
15.4
15.4
15.3
15.2
15.1
1 2
Friability
0.122
0.12
0.12
0.118
0.116
0.114
(% w/w)
0.112
0.11
0.11
0.108
0.106
0.104
1 2
0.11
0.108
0.106
0.104
1 2
Dissolution
103.00%
102.10%
102.00%
101.00%
100.30%
100.00%
98.70%
(D)%
99.00%
98.00% 97.80%
97.00%
96.00%
95.00%
Min Max
8038 8041
Assay
99.40%
99.30%
99.20%
99.00%
98.80%
98.60%
98.50%
98.40%
98.20%
98.00%
1 2
98.80%
98.60%
98.50%
98.40%
98.20%
98.00%
1 2
(F.Y. 78/79)
Product Name: Telsan-20 Tablets
Batch Sifting of Average Thickness Diameter Hardness Friability Assay

Preparation Semi DT
No: Sifting Granulation dried Drying Lubrication Wt. (mg) (mm) (mm) (Kg/cm2) (%w/w) Min Max (Telmisartan)
of Active Drying
granules
8023 30 40 10 30 30 10 15 201.8 6 min 56 sec 3.66 8.23 8 0.007 98.60% 101.80% 106.10%
s
(F.Y. 78/79)
Product Name: Telsan-40 Tablets

Batch Sifting of Average Thickness Length Hardness Friability Assay
Preparation Semi DT
No: Sifting Granulation dried Drying Lubrication Wt. (mg) (mm) (mm) (Kg/cm2) (%w/w) Min Max (Telmisartan)
of Active Drying
granules
8024 30 45 20 20 30 20 20 501.9 4 min 10 sec 4.4 16.04 12.1 0.08 102.30% 105.30% 105.30%
(F.Y. 78/79)
Product Name: Atosta-10 Tablets

Average Thickness Diameter Assay
Batch No:
Sifting Mixing Lubrication Wt. (mg) Min Max (mm) (mm) Min Max (Atorvastatin)
8025 65 20 20 100.4 96.80% 109.90% 3 6.69 90.10% 97.60% 108.70%

8026 85 30 10 100.2 84.10% 104.10% 2.92 6.61 92.80% 97.90% 109.70%
Manufacturing Time
90 85
80
70 65
60
50
Min
40
30
30
20 20
20
10
10
0
8025 8026
Average wt.
100.45
100.4
100.4
100.35
100.3
(mg)
100.25
100.2
100.2
100.15
100.1
100.05
1 2
Uniformity of content
120.00%
109.90%
104.10%
100.00% 96.80%
84.10%
80.00%
60.00%
40.00%
20.00%
0.00%
Min Max
8025 8026
Thickness
3.02
3
3
2.98
2.96
mm
2.94
2.92
2.92
2.9
2.88
1 2
Diameter
6.7 6.69
6.68
6.66
6.64
mm
6.62 6.61
6.6
6.58
6.56
1 2
6.62 6.61
6.6
6.58
6.56
1 2
Dissolution
100.00%
97.60% 97.90%
98.00%
96.00%
94.00%
92.80%
(D)%
92.00%
90.10%
90.00%
88.00%
86.00%
1 2
Min Max
Assay
109.80% 109.70%
109.60%
109.40%
109.20%
109.00%
108.80% 108.70%
108.60%
108.40%
108.20%
108.00%
1 2
(F.Y. 78/79)
Product Name: Atosta-20 Tablets

Batch Average Thickness Diameter Assay
No: Sifting Mixing Lubrication Wt. (mg) (mm) (mm) Min Max (Atorvastatin)
8005 30 30 10 122.6 3.41 6.43 89.60% 103.60% 103.60%

(F.Y. 78/79)
Product Name: Acosart-25 Tablets
Manufacturing Time (min) Dissolution (D)% Assay

Batch Average Thickness Diameter
DT (Losartan
No: Sifting Mixing Lubrication Wt. (mg) (mm) (mm) Min Max Potassium)
8007 30 20 20 153.9 6 min 10 sec 3.75 7.2 105.40% 112.10% 107.30%
(F.Y. 78/79)
Product Name: Acosart-50 Tablets
Manufacturing Time (min) Dissolution (D)% Assay

Batch Average Thickness Diameter
DT (Losartan
No: Sifting Mixing Lubrication Wt. (mg) (mm) (mm) Min Max Potassium)
8035 45 30 10 149.1 7 min 08 secs 3.64 7.24 96.30% 110.60% 108.60%
8117 75 20 5 150.2 7 min 13 secs 3.3 7.06 107.60% 112.80% 101.50%
Manufacturing Time
80 75
70
60
50 45
40
30
30
20
20
10
10 5
0
8035 8117
Average Wt.
150.4
150.2
150.2
150
149.8
149.6
149.4
149.2 149.1
149
148.8
148.6
148.4
1 2
DT
3.7
3.64
3.6
3.5
3.4
3.3
3.3
3.2
3.1
1 2
Thickness
3.7
3.64
3.6
3.5
3.4
3.3
3.3
3.2
3.1
1 2
Diameter
7.3
7.25 7.24
7.2
7.15
7.1
7.06
7.05
6.95
1 2
Dissolution
115.00% 112.80%
110.60%
110.00% 107.60%
105.00%
100.00%
96.30%
95.00%
90.00%
85.00%
Min Max
8035 8117
Assay
110.00%
108.60%
108.00%
106.00%
104.00%
102.00% 101.50%
100.00%
98.00%
96.00%
1 2
102.00% 101.50%
100.00%
98.00%
96.00%
1 2
(F.Y. 78/79)
Product Name: Acosart-H Tablet
Manufacturing Time (min) Dissolution % (D) Assay

Average Thickness Diameter Uniformity of content (%w/w) Losartan Potassium Hydrochlorothiazide
Batch No: DT Losartan
Sifting Mixing Lubrication Wt. (mg) (mm) (mm) Hydrochlorothiazide
Min Max Min Max Min Max Potassium
8036 50 30 10 168.07 4 min 40 sec 3.28 8.25 91.5 103.1 89.1 96.1 98.5 102.1 103.70% 101.30%
(F.Y. 78/79)
Product Name: Cutimom Cream (15g)
Mixing time(min)
Assay
Before Avg.wt.
Batch No: After addition pH (Momentasone
addition of (g)
of API Furoate)
API
8008 280 105 5.32 15.00 108.70%
8105 260 120 5.6 15.1 100.80%
Mixing Time
300 280
260
250
200
(min)
150
120
105
100
50
0
1 2
pH
5.65
5.6
5.6
5.55
5.5
5.45
5.4
5.35 5.32
5.3
5.25
5.2
5.15
1 2
5.3
5.25
5.2
5.15
1 2
Average Wt.
15.12
15.1
15.10
15.08
15.06
15.04
15.02
15.00
15.00
14.98
14.96
14.94
1 2
Assay
110.00%
108.70%
108.00%
106.00%
104.00%
102.00%
100.80%
100.00%
98.00%
96.00%
1 2
(F.Y. 78/79)
Product Name: Fluact Cream (15g)
Mixing time(min)
Assay
Batch Before After Avg.wt.
pH (Fluticasone
No: addition of addition of (g)
Propionate)
API API
8045 150 110 4.86 15.30 102.00%
(F.Y. 78/79)
Product Name: Terif Cream (15g)
Mixing time(min)
Assay
Batch No: pH (Terbinafine
HCL)
API API
8020 175 160 5.25 15.08 100.00%
(F.Y. 78/79)
Product Name: Allerfix Suspension (60 ml)
Mixing time (min)

Avg. fill Weight Assay
Batch No: Before After pH volume per ml (Fexofenadine
addition of addition of (ml) (g) HCL)
API API
8022 280 150 6.13 60.5 1.13 103.10%
8064 380 130 5.97 60.3 1.1 100.80%
8092 285 150 6 60.6 1.13 103.90%
Mixing Time
400 380
350
300 280 285
250
(min)
200
150 150
150 130
100
50
0
1 2 3
pH
6.15 6.13
6.1
6.05
6
6
5.97
5.95
5.9
5.85
1 2 3
Avg. fill volume
60.65
60.6
60.6
60.55
60.5
60.5
60.45
60.4
(ml)
60.35
60.3
60.3
60.25
60.2
60.15
60.1
1 2 3
Weight per ml
1.135
1.13 1.13
1.13
1.125
1.12
1.115
(g)
1.11
1.105
1.1
1.1
1.095
1.09
1.085
1 2 3
Assay
104.50%
103.90%
104.00%
103.50% 103.10%
103.00%
102.50%
102.00%
101.50%
101.00% 100.80%
100.50%
100.00%
99.50%
99.00%
1 2 3
102.50%
102.00%
101.50%
101.00% 100.80%
100.50%
100.00%
99.50%
99.00%
1 2 3
(F.Y. 78/79)
Product Name: Allerfix Suspension (100 ml)
Mixing time (min)

Batch No: Before After pH volume per ml (Fexofenadine
addition of addition of (ml) (g) HCL)
API API
8109 170 120 6.6 101.5 1.086 98.50%
(F.Y. 78/79)
Product Name: Dex Kof Syrup (100 ml)

Avg. fill Weight
Batch No: Before After pH volume per ml
addition of addition of (ml) (g) Dextromethorphan Phenylephrine Triprolidine
API API
8021 85 160 4.6 100.5 1.14 104.50% 102.40% 103.70%
(F.Y. 78/79)
Product Name: Sucfate Suspension (200 ml)
Mixing time (min)

Avg. fill Weight
Before After Assay
addition of addition of (Sucralfate)
(ml) (g)
API API
8028 325 240 5.21 200.3 1.12 105.20%
8029 250 210 5.34 200.7 1.12 107.50%
8056 330 90 5.48 201 1.12 104.90%
8085 360 90 5.5 200.9 1.12 99.40%
8086 300 160 5.51 201.6 1.12 98.60%
8088 320 180 5.39 200.7 1.12 98.80%
8089 295 200 5.76 201.8 1.12 101.20%
Mixing time
400
360
350 325 330 320
300 295
300
240 250
250
210
Min
200
200 180
160
150
90 90
100
50
0
1 2 3 4 5 6 7
pH
5.9
5.8 5.76
5.7
5.6
5.5 5.51
5.48
5.5
5.39
5.4 5.34
5.3
5.21
5.2
5.1
5
4.9
1 2 3 4 5 6 7
5.3
5.21
5.2
5.1
5
4.9
1 2 3 4 5 6 7
Avg. fill volume

202 201.8
201.6
201.5
201
201 200.9
200.7 200.7
ml
200.5
200.3
200
199.5
1 2 3 4 5 6 7
Weight per ml
1.2 1.12 1.12 1.12 1.12 1.12 1.12 1.12
0.8
0.6
0.4
0.2
0
1 2 3 4 5 6 7
Assay (Sucralfate)
110.00%
108.00% 107.50%
106.00% 105.20% 104.90%

104.00%
102.00% 101.20%
100.00% 99.40%
98.60% 98.80%
98.00%
96.00%
94.00%
1 2 3 4 5 6 7
104.00%
102.00% 101.20%
100.00% 99.40%
98.60% 98.80%
98.00%
96.00%
94.00%
1 2 3 4 5 6 7
(F.Y. 78/79)
Product Name: Acolev Syrup (60ml)
Mixing time (min)

Avg. fill Weight
Before After Assay (Levocitrizine
addition addition Dihydrochloride)
(ml) (g)
of API of API
8083 60 100 5.04 61.5 1.12 106.70%
(F.Y. 78/79)
Product Name: Acotus Syrup (60ml)

Avg. fill Weight
Batch No: Before After pH volume per ml Bromhexine Terbutaline
addition of addition of (ml) (g) HCL Sulphate
API API
8099 100 90 3.87 61.2 1.06 100.80% 104.30%
(F.Y. 78/79)
Product Name: Acotus Syrup (100ml)

Avg. fill Weight
addition of addition of (ml) (g) HCL Sulphate
API API
8103 60 60 3.93 100.1 1.05 102.60% 101.80%
(F.Y. 78/79)
Product Name: Acotus XT Syrup

Avg. fill Weight
addition addition (ml) (g) HCL Sulphate
of API of API
8104 90 50 3.89 100.7 1.09 102.90% 105.10%
(F.Y. 78/79)
Product Name: Topiket Cream (15g)
Mixing time(min)
Batch No: pH
addition of addition of (g) (Ketoconazole)
API API
8042 235 135 7.25 15.04 103.90%
8107 120 80 7.17 15 104.10%
Mixing Time
250 235
200
150 135
120
(min)
100 80
50
0
1 2
pH
7.26 7.25
7.24
7.22
7.2
7.18 7.17
7.16
7.14
7.12
1 2
Avg wt.
15.05
15.04
15.04
15.03
15.02
15.01
15
15.00
14.99
14.98
1 2
Assay
104.15%
104.10%
104.10%
104.05%
104.00%
103.95%
103.90%
103.90%
103.85%
103.80%
103.75%
1 2
(F.Y. 78/79)
Product Name: Aclear Gel (15g)
Mixing time(min)
pH
No: addition of addition of (g) (Adapalene)
API API
8034 180 95 4.85 15.10 104.00%
(F.Y. 78/79)
Product Name: Acoplex Syrup (200ml)

Avg. fill Weight
Batch No. Before After pH volume per ml Thiamine Pyridoxine
addition of addition of (ml) (g) Riboflavin Nicotinamide
Hydrochloride Hydrochloride
API API
8048 240 380 4.85 202.9 1.2 146.70% 143.00% 135.60% 127.20%
8049 150 390 4.88 202.5 1.2 148.20% 141.20% 134.00% 127.90%
Mixing time
450
400 380 390
350
300
250 240
Min
200
150
150
100
50
0
1 2

pH
4.885
4.88
4.88
4.875
4.87
4.865
4.86
4.855
4.85
4.85
4.845
4.84
4.835
4.83
1 2
Avg. fill volume

203
202.9
202.9
202.8
202.7
ml
202.6
202.5
202.5
202.4
202.3
1 2
202.6
202.5
202.5
202.4
202.3
1 2
Weight per ml
1.4
1.2 1.2
1.2
0.8
\
0.6
0.4
0.2
0
1 2
Axis Title
Assay
148.20%
150.00%
146.70%
141.20%
145.00% 143.00%
134.00%
140.00%
135.60% 127.90%
135.00%
130.00% 127.20%
125.00%
120.00%
115.00%
Thiamine Hydrochloride Riboflavin Pyridoxine Hydrochloride Nicotinamide
8048 8049
130.00% 127.20%
125.00%
120.00%
115.00%
Thiamine Hydrochloride Riboflavin Pyridoxine Hydrochloride Nicotinamide
8048 8049
(F.Y. 78/79)
Product Name: Clara Syrup (60 ml)
Mixing time (min)

Avg. fill
Before After Weight per Assay
Batch No: pH volume
addition of addition of ml (g) (Loratadine)
(ml)
API API
8027 50 110 2.86 60.5 1.11 104.70%
8098 240 120 2.59 61.5 1.11 98.60%
Mixing Time
300
250 240
200
150
110 120
100
50
50
0
1 2
pH
2.9
2.86
2.85
2.8
2.75
2.7
2.65
2.59
2.6
2.55
2.5
2.45
1 2
Avg. fill volume
61.6 61.5
61.4
61.2
61
60.8
60.6 60.5
60.4
60.2
60
1 2
Weight per ml
1.2 1.11 1.11
0.8
0.6
0.4
0.2
0
1 2
Assay
106.00%
104.70%
104.00%
102.00%
100.00%
98.60%
98.00%
96.00%
94.00%
1 2
100.00%
98.60%
98.00%
96.00%
94.00%
1 2
(F.Y. 78/79)
Product Name: Ecoxib 90 Tablets

Batch Preparation Average Thickness Diameter Assay
No: Sifting Mixing of Binder Granulation Lubrication Wt. (mg) (mm) (mm) Min Max (Etoricoxib)
Solution
8050 65 30 90 10 10 231 3.91 8.24 88.70% 89.80% 102.00%
8069 120 30 160 10 15 227.6 3.89 8.24 85.40% 89.90% 99.10%
Manufacturing Time
180
160
160
140
120
120
100 90
Min
80 65
60
40 30 30
20 10 10 10 15
0
Sifting Mixing Preparation of Granulation Lubrication
Binder Solution
8050 8069
Average Wt.
232
231
231
230
229
(mg)
228 227.6
227
226
225
1 2
Thickness
3.915
3.91
3.91
3.905
3.9
(mm)
3.895
3.89
3.89
3.885
3.88
1 2
9
Diameter
8.24 8.24
8
7
6
5
(mm)
4
3
2
1
0
1 2
Dissolution
91.00%
89.80% 89.90%
90.00%
89.00% 88.70%
(D)%
88.00%
87.00%
86.00% 85.40%
85.00%
84.00%
83.00%
Min Max
8050 8069
84.00%
83.00%
Min Max
8050 8069
Assay
102.50%
102.00%
102.00%
101.50%
101.00%
100.50%
100.00%
99.50% 99.10%
99.00%
98.50%
98.00%
97.50%
1 2
(F.Y. 78/79)

Solution
8073 40 20 60 15 15 228.9 3.89 8.25 90.50% 95.40% 98.50%
8108 80 30 90 5 5 230.2 3.73 8.24 97.40% 109.40% 104.30%
Manufacturing Time
100 90
80
80
60
60
40
(min)
40 30
20
20 15 15
5 5
0
Binder Solution
Axis Title
8073 8108
Average Weight
230.4
230.2
230.2
230
229.8
229.6
229.4
229.2
229 228.9
228.8
228.6
228.4
228.2
1 2
Thickness
3.95
3.9 3.89
3.85
3.8
3.75 3.73
3.7
3.65
1 2
3.75 3.73
3.7
3.65
1 2
Diameter
8.252
8.25
8.25
8.248
8.246
8.244
8.242
8.24
8.24
8.238
8.236
8.234
1 2
Dissolution
120.00% 109.40%
97.40% 95.40%
100.00% 90.50%
80.00%
60.00%
40.00%
20.00%
0.00%
Min Max
8073 8108
20.00%
0.00%
Min Max
8073 8108
Assay
105.00% 104.30%
104.00%
103.00%
102.00%
101.00%
100.00%
99.00% 98.50%
98.00%
97.00%
96.00%
95.00%
1 2
(F.Y. 78/79)

Solution
8074 25 30 70 15 15 228.5 4.09 8.26 81.30% 86.00% 102.70%

8110 90 15 60 10 10 228 3.88 8.14 92.00% 94.90% 101.10%
Manufacturing Time
100 90
90
80 70
70 60
60
50
40 30
30 25
20 15 15 15
10 10
10
0
Binder Solution
8074 8110
Average Wt.
228.6
228.5
228.5
228.4
228.3
228.2
228.1
228
228
227.9
227.8
227.7
1 2
Thickness
4.15
4.1 4.09
4.05
3.95
3.9 3.88
3.85
3.8
3.75
1 2
Diameter
8.28
8.26
8.26
8.24
8.22
8.2
8.18
8.16
8.14
8.14
8.12
8.1
8.08
1 2
Dissolution
100.00%
94.90%
95.00%
92.00%
90.00%
86.00%
85.00%
81.30%
80.00%
75.00%
70.00%
Min Max
8074 8110
80.00%
75.00%
70.00%
Min Max
8074 8110
Assay
103.00%
102.70%
102.50%
102.00%
101.50%
101.10%
101.00%
100.50%
100.00%
1 2
(F.Y. 78/79)
Product Name: Looptor-5 Tablets

No: Sifting Mixing Granulation Lubrication Wt. (mg) Min Max (mm) (mm) Min Max (Torsemide)
8051 35 20 10 10 101.03 92.10% 104.90% 2.97 6.43 88.30% 92.80% 100.10%

8053 45 20 10 10 102.6 92.70% 102.30% 2.98 6.43 103.10% 107.70% 108.00%
Manufacturing Time
50
45
45
40
35
35
30
25
Min
20 20
20
15
10 10 10 10
10
5
0
Sifting Mixing Granulation Lubrication
8051 8053
Average Wt.
103
102.6
102.5
102
101.5
mg
101.03
101
100.5
100
1 2
110.00%
104.90%
105.00%
102.30%
100.00%
95.00%
92.10% 92.70%
90.00%
85.00%
Min Max
8051 8053
90.00%
85.00%
Min Max
8051 8053
Thickness
2.982
2.98
2.98
2.978
2.976
2.974
(mm)
2.972
2.97
2.97
2.968
2.966
2.964
1 2
Diameter
7
6.43 6.43
4
(mm)
0
1 2
2
0
1 2
Dissolution
120.00%
107.70%
103.10%
100.00% 92.80%
88.30%
80.00%
(D)%
60.00%
40.00%
20.00%
0.00%
Min Max
8051 8053
Assay
110.00%
108.00%
108.00%
106.00%
104.00%
102.00%
100.10%
100.00%
98.00%
96.00%
1 2
102.00%
100.10%
100.00%
98.00%
96.00%
1 2
(F.Y. 78/79)

Average Wt. Thickness Diameter Assay
Batch No:
Sifting Mixing Granulation Lubrication (mg) Min Max (mm) (mm) Min Max (Torsemide)
8046 20 20 10 10 107.7 97.50% 103.40% 3.1 6.45 101.40% 116.60% 107.10%

8054 55 20 10 10 107.2 97.30% 102.20% 3.1 6.45 100.30% 107.50% 108.20%
Manufacturing Time
60
55
50
40
(Min)
30
20 20 20
20
10 10 10 10
10
0
8046 8054
Average Wt.
107.8
107.7
107.7
107.6
107.5
107.4
(mg)
107.3
107.2
107.2
107.1
107
106.9
1 2
104.00% 103.40%
103.00%
102.20%
102.00%
101.00%
100.00%
99.00%
98.00% 97.50% 97.30%
97.00%
96.00%
95.00%
94.00%
Min Max
8046 8054
Thickness
3.5
3.1 3.1
3
2.5
2
(mm)
1.5
0.5
0
1 2
Diameter
7
6.45 6.45
4
(mm)
0
1 2
5
(mm)
3
0
1 2
Dissolution
120.00%
116.60%
115.00%
110.00%
107.50%
105.00%
101.40%
100.30%
100.00%
95.00%
90.00%
Min Max
8046 8054
Assay
108.40%
108.20%
108.20%
108.00%
107.80%
107.60%
107.40%
107.20% 107.10%
107.00%
106.80%
106.60%
106.40%
1 2
108.00%
107.80%
107.60%
107.40%
107.20% 107.10%
107.00%
106.80%
106.60%
106.40%
1 2
(F.Y. 78/79)

No: Sifting Mixing Granulation Lubrication Wt. (mg) (mm) (mm) Min Max (Torsemide)
8052 90 20 10 10 170.4 3.96 7.23 94.20% 101.40% 102.60%

8055 75 20 10 10 173.3 4.03 7.29 95.50% 107.60% 104.90%
Manufacturing Time
100
90
90
80 75
70
60
(min)
50
40
30
20 20
20
10 10 10 10
10
0
8052 8055
Average wt.
174
173.3
173
172
(mm)
171
170.4
170
169
168
1 2
Thickness
4.04 4.03
4.02
4
(mm)
3.98
3.96
3.96
3.94
3.92
1 2
3.96
3.94
3.92
1 2
Diameter
7.3
7.29
7.29
7.28
7.27
7.26
(mm)
7.25
7.24
7.23
7.23
7.22
7.21
7.2
1 2
Dissolution
110.00%
107.60%
105.00%
101.40%
100.00%
95.50%
95.00% 94.20%
90.00%
85.00%
Min Max
8052 8055
90.00%
85.00%
Min Max
8052 8055
Assay
105.50%
104.90%
105.00%
104.50%
104.00%
103.50%
103.00%
102.60%
102.50%
102.00%
101.50%
101.00%
1 2
(F.Y. 78/79)
Product Name: Rosva 5 Tablets

No: Sifting Mixing Granulation Lubrication Wt. (mg) Min Max (mm) (mm) Min Max (Rosuvastatin)
8112 45 20 15 55 117.6 95.10% 109.80% 3.18 6.43 87.00% 96.80% 103.90%

(F.Y. 78/79)

No: Sifting Mixing Granulation Lubrication Wt. (mg) Min Max (mm) (mm) Min Max (Rosuvastatin)
8113 45 25 30 15 130.2 97.70% 101.30% 3.53 6.44 93.60% 98.70% 104.50%

(F.Y. 78/79)

No: Sifting Mixing Granulation Lubrication Wt. (mg) (mm) (mm) Min Max (Rosuvastatin)
8114 35 20 5 5 172.9 4.2 7.21 100.60% 104.90% 104.00%

(F.Y. 78/79)
Product Name: Sitavia-50 Tablets

Batch Preparation of Average Thickness Diameter Assay
No: Sifting Mixing Binder Granulation Lubrication Wt. (mg) (mm) (mm) (Sitagliptin)
Solution
8093 25 20 35 40 5 173 7.22 3.79 100.70%
(F.Y. 78/79)
Product Name: Sitavia-100 Tablets

No: Sifting Mixing of Binder Granulation Drying Lubrication Wt. (mg) (mm) (mm) (Sitagliptin)
Solution
8094 35 20 60 60 90 5 271.3 3.96 9.03 99.00%
(F.Y. 78/79)
Product Name:Acomet Suspension (60ml)
Mixing time (min)

Batch Before After pH volume per ml (Metronidazole
No: addition of addition of (ml) (g) Benzoate )
API API
8060 240 90 5.56 60.5 1.03 107.50%
(F.Y. 78/79)
Product Name: Acomet-DF Suspension (60ml)

Avg. fill Weight
Batch No: Before After pH volume per ml Metronidazole Diloxanide
addition of addition of (ml) (g) Benzoate Furoate
API API
8061 390 80 5.81 61.8 1.02 107.00% 107.50%
(F.Y. 78/79)
Product Name: Glotin-0.025 Gel (15g)
Mixing time(min)
pH
No: addition of addition of (g) (Tretinoin)
API API
8065 120 80 6.19 15.02 129.60%
(F.Y. 78/79)
Product Name: Glotin-0.05 Gel (15g)
Mixing time(min)
pH
No: addition of addition of (g) (Tretinoin)
API API
8066 190 75 5.7 15.05 129.70%
(F.Y. 78/79)
Product Name: Rumonac Gel (30g)
Mixing Time(min) Assay

Batch No: pH Diclofenac Methyl
Diethylamine Salicylate
API API
8058 210 150 7.05 30.05 105.10% 104.60%
8059 540 75 6.86 30.12 104.50% 105.80%
Mixing Time
600
540
500
400
300
Min
210
200 150
100 75
0
1 2
pH
7.1
7.05
7.05
6.95
6.9
6.86
6.85
6.8
6.75
1 2
Avg.wt.
30.14
30.12
30.12
30.10
30.08
g
30.06 30.05
30.04
30.02
30.00
1 2
Assay
106.00% 105.80%
105.50%
105.10%
105.00%
104.60%
104.50%
104.50%
104.00%
103.50%
1 2
Diclofenac Diethylamine Methyl Salicylate

(F.Y. 78/79)
Product Name: Acloba Cream (15g)
Mixing time(min)
Assay
pH (Clobetasol
Propionate)
API API
8081 170 145 5.62 15.19 102.20%
(F.Y. 78/79)
Product Name: Acloba-G Cream (15g)

pH Clobetasol
No: addition of addition of (g) Gentamicin
Propionate
API API
8062 170 135 4.85 15.09 100.50% 102.45%
8123 210 120 5.07 15.33 106.60% 104%
Mixing Time
250
210
200
170
150 135
120
100
50
0
1 2
pH
5.1 5.07
5.05
4.95
4.9
4.85
4.85
4.8
4.75
4.7
1 2
Avg.wt.
15.35 15.33
15.30
15.25
15.20
15.15
15.10 15.09
15.05
15.00
14.95
1 2
Assay
108.00%
106.60%
106.00%
104%
104.00%
102.45%
102.00%
100.50%
100.00%
98.00%
96.00%
1 2
Clobetasol Propionate Gentamicin

(F.Y. 78/79)
Product Name: Acloba-GM Cream (15g)

Batch No: Before After pH Avg.wt. (g) Clobetasol
addition of addition of Gentamicin Miconazole Nitrate
Propionate
API API
8063 145 150 4.87 15.26 104.10% 102.66% 98.90%
8124 170 135 5.32 15.41 108.60% 100.80% 102.90%
Mixing Time
180 170
160 145 150
140 135
120
100
80
60
40
20
0
1 2

pH
5.4
5.32
5.3
5.2
5.1
4.9 4.87
4.8
4.7
4.6
1 2
Avg.wt.
15.45
15.40
15.35
15.30
15.25
15.20
15.15
1 2
15.25
15.20
15.15
1 2
Assay
110.00% 108.60%
108.00%
106.00%
104.10%
104.00% 102.66% 102.90%
102.00% 100.80%
100.00% 98.90%
98.00%
96.00%
94.00%
Clobetasol Propionate Gentamicin Miconazole Nitrate
8063 8124
(F.Y. 78/79)
Product Name: Halotop Cream (15g)
Mixing time(min)
Assay
pH (Halobetasol
Propionate)
API API
8067 160 90 6.24 15.09 103.50%
(F.Y. 78/79)
Product Name: Halotop-G Cream (15g)
Mixing time(min) Assay

pH Halobetasol
No: addition of addition of (g) Gentamicin
Propionate
API API
8068 160 140 5.36 15.04 107.00% 100.37%
(F.Y. 78/79)
Product Name: Prozin Syrup (60ml)
Mixing time (min)

Batch No: Before After pH volume per ml (Promethazine
addition of addition of (ml) (g) HCL )
API API
8070 210 80 4.9 60.7 1.1 104.10%
8101 150 205 5.04 60.1 1.1 104.20%
Mixing Time
250
210 205
200
150
150
(min)
100 80
50
0
1 2
pH
5.1
5.05 5.04
4.95
4.9
4.9
4.85
4.8
1 2
Avg. fill volume
60.8
60.7
60.6
60.4
60.2
(ml)
60.1
60
59.8
59.6
1 2
Weight per ml
1.2
1.1 1.1
0.8
0.6
0.4
0.2
0
1 2
Assay
104.22%
104.20%
104.20%
104.18%
104.16%
104.14%
104.12%
104.10%
104.10%
104.08%
104.06%
104.04%
1 2
104.12%
104.10%
104.10%
104.08%
104.06%
104.04%
1 2
(F.Y. 78/79)
Product Name: Lijenta 2.5 Tablets

Average Wt. Thickness Diameter Assay
Batch No:
Sifting Mixing Granulation Lubrication (mg) Min Max (mm) (mm) Min Max (Linagliptin)
8084 40 20 30 20 114.7 95.50% 106.80% 3.34 6.48 104.90% 115.60% 104.90%

8125 60 30 20 30 112.8 90.60% 93.50% 3.18 6.47 90.60% 96.00% 100.20%
Manufacturing Time
70
60
60
50
40
40
30 30 30
30
20 20 20
20
10
0
8084 8125
Average Wt.
115
114.7
114.5
114
113.5
113 112.8
112.5
112
111.5
1 2
110.00%
106.80%
105.00%
100.00%
95.50%
95.00% 93.50%
90.60%
90.00%
85.00%
80.00%
Min Max
8084 8125
Thickness
3.4
3.35 3.34
3.3
3.25
3.2 3.18
3.15
3.1
1 2
Diameter
6.482
6.48
6.48
6.478
6.476
6.474
6.472
6.47
6.47
6.468
6.466
6.464
1 2
6.468
6.466
6.464
1 2
Dissolution
140.00%
120.00% 115.60%
104.90%
100.00% 96.00%
90.60%
80.00%
60.00%
40.00%
20.00%
0.00%
Min Max
8084 8125
Assay
106.00%
104.90%
105.00%
104.00%
103.00%
102.00%
101.00%
100.20%
100.00%
99.00%
98.00%
97.00%
1 2
100.00%
99.00%
98.00%
97.00%
1 2
(F.Y. 78/79)
Product Name: Lijenta 5 Tablets

Average Thickness Diameter Assay
Batch No: Roll
Sifting Mixing Lubrication Wt. (mg) Min Max (mm) (mm) Min Max (Linagliptin)
Compaction
8082 30 20 30 10 112 113.40% 114.70% 3.2 6.43 107.20% 111.50% 99.00%

8126 55 25 100 5 114.8 103.90% 108.80% 3.21 6.43 101.00% 106.00% 103.30%
Manufacturing Time
120
100
100
80
60 55
40
30 30
25
20
20
10
5
0
Sifting Mixing Roll Compaction Lubrication
8082 8126
Average Wt.
115.5
115 114.8
114.5
114
113.5
113
112.5
112
112
111.5
111
110.5
1 2
116.00% 114.70%
114.00% 113.40%
112.00%
110.00% 108.80%
108.00%
106.00%
103.90%
104.00%
102.00%
100.00%
98.00%
Min Max
8082 8126
100.00%
98.00%
Min Max
8082 8126
Thickness
3.212
3.21
3.21
3.208
3.206
3.204
3.202
3.2
3.2
3.198
3.196
3.194
1 2
Diameter
7
6.43 6.43
0
1 2
2
0
1 2
Dissolution
114.00%
112.00% 111.50%
110.00%
108.00% 107.20%
106.00%
106.00%
104.00%
102.00% 101.00%
100.00%
98.00%
96.00%
94.00%
Min Max
8082 8126
Assay
104.00%
103.30%
103.00%
102.00%
101.00%
100.00%
99.00%
99.00%
98.00%
97.00%
96.00%
1 2
99.00%
99.00%
98.00%
97.00%
96.00%
1 2
(F.Y. 78/79)
Product Name: Acovit C Tablets
Manufacturing Time (min) Assay

Average Friability Thickness Diameter
Batch No: Hardness (Ascorbic
Sifting Mixing Granulation Lubrication Wt. (mg) (%w/w) (mm) (mm)
Acid)
8090 110 35 60 20 794.9 0.08 14 4.27 12.8 98.40%
(F.Y. 78/79)
Product Name: Acolev Tablets
Manufacturing Time (min) Uniformity of Content Dissolution % (D) Assay

Batch Average Thickness
Hardness Diameter (mm) (Levocitrizine
No: Sifting Mixing Granulation Lubrication Wt. (mg) Min Max (mm) Min Max (2HCl )
8087 30 20 15 10 103.2 97.40% 101.40% 8.2 2.99 6.46 95.60% 98.50% 101.80%
(F.Y. 78/79)
Product Name: Clotrim Cream (15g)
Mixing time(min)
pH
No: addition of addition of (g) (Clotrimazole)
API API
8111 240 120 5.98 15.10 102.30%
(F.Y. 78/79)
Product Name: Zoom-250 Tablets
Manufacturing Time (min) Dissolution % (D)

No: Prepration of Wt. (mg) (mm) (mm) (Azithromycin)
Sifting binder Granulation Drying Lubrication Min Max
solution
8121 50 90 20 120 15 402.1 4.79 11.29 99.50% 115.10% 102.50%

(F.Y. 78/79)
Product Name: Zoom-500 Tablets
Manufacturing Time (min) Dissolution % (D)

Batch Prepration Average Thickness Length Assay
No: Sifting of binder Granulation Drying Lubrication Wt. (mg) (mm) (mm) Min Max (Azithromycin)
solution
8122 180 50 20 60 25 725.7 5.38 18.2 84.50% 102.20% 102.20%

Apr 78

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Annual Product Review (APR)

Manufacturing Time (min) Uniformity of content(%) Dissolution (D)% Assay

Manufacturing Time (min) Uniformity of content(%) Dissolution (D)% Assay

Manufacturing Time (min) Uniformity of content(%) Dissolution (D)% Assay

Manufacturing Time (min) Uniformity of content(%) Dissolution % (D) Assay

Amlodipine Losartan Potassium

Manufacturing Time (min) Uniformity of content(%) Dissolution % (D) Assay

Amlodipine Losartan Potassium

Manufacturing Time (min) Uniformity of content(%) Dissolution (D)%

Manufacturing Time (min) Uniformity of content(%) Dissolution (D)%

Mixing time (min)

Before addition of API After addition of API

Avg. fill volume

Mixing time(min) Assay

Before addition of API After addition of API

102.00% 100.80% 100.60%

Mixing time (min)

Before addition of API After addition of API

Avg. fill volume

1.2 1.19 1.19 1.19

Mixing time (min) Assay

Before addition of API After addition of API

Manufacturing Time (min)

0.21 103.40% 124.10% 98.40%

Manufacturing Time (min) Dissolution (D)%

Manufacturing Time (min) Dissolution (D)%

Batch Sifting of Average Thickness Diameter Hardness Friability Assay

Manufacturing Time (min) Dissolution (D)%

Manufacturing Time (min) Uniformity of content(%) Dissolution (D)%

8025 65 20 20 100.4 96.80% 109.90% 3 6.69 90.10% 97.60% 108.70%

Manufacturing Time (min) Dissolution (D)%

8005 30 30 10 122.6 3.41 6.43 89.60% 103.60% 103.60%

Manufacturing Time (min) Dissolution (D)% Assay

Manufacturing Time (min) Dissolution (D)% Assay

Manufacturing Time (min) Dissolution % (D) Assay

Before addition of API After addition of API

Mixing time (min)

Before addition of API After addition of API

Mixing time (min)

Mixing time (min) Assay

Mixing time (min)

Before addition of API After addition of API

Avg. fill volume

106.00% 105.20% 104.90%

Mixing time (min)

Mixing time (min) Assay

Mixing time (min) Assay

Mixing time (min) Assay

Before addition of API After addition of API

Mixing time (min) Assay

Before addition of API After addition of API

Avg. fill volume

Mixing time (min)

Before addition of API After addition of API

Manufacturing Time (min) Dissolution (D)%

Manufacturing Time (min) Dissolution (D)%

Manufacturing Time (min) Dissolution (D)%

8074 25 30 70 15 15 228.5 4.09 8.26 81.30% 86.00% 102.70%

Manufacturing Time (min) Uniformity of content(%) Dissolution (D)%

8051 35 20 10 10 101.03 92.10% 104.90% 2.97 6.43 88.30% 92.80% 100.10%

Manufacturing Time (min) Uniformity of content(%) Dissolution (D)%

8046 20 20 10 10 107.7 97.50% 103.40% 3.1 6.45 101.40% 116.60% 107.10%