Dossi

Dosage
S.No Product Name Therapeutic Segment
Form

1 Aspirin 100mg Tablet Analgesic/ CD

Bromhexine hydrochloride
2 Tablets Mucolytics
8mg
Dimenhydrinate 50mg,
3 Hyoscine Hydrobromide Tablet Antiemetic
0.2mg & Caffeine 20mg
4 Diclofenac Potassium 12.5mg Tablet Analgesic

5 Diclofenac Potassium 25mg Tablet Analgesic

6 Diclofenac Potassium 50mg Tablet Analgesic

Docusate Sodium 50mg +

7 Tablet Stool softener
Calcium Sennosides 8mg
Mini
8 Esomeprazole 20mg PPI
capsules

9 Famciclovir 500mg Tablet Anti herpes virus

10 Fexofenadine 120mg Tablet Antihistamine

11 Fexofenadine 180mg Tablet Antihistamine

12 Fluoxetine 20mg Capsule Antidepressant

13 Fluoxetine 40mg Capsule Antidepressant

14 Gabapentin 300mg Capsule Anticonvulsant

15 Hyoscine Butylbromide 10mg Tablet Anti GI spasm

16 Hyoscine Butylbromide 20mg Tablet Anti GI spasm

17 Ibuprofen 200mg Tablet Analgesic

18 Ibuprofen 400mg Tablet Analgesic

 Ibuprofen Sodium dihydrate
19 Tablet Analgesic
256mg
Ibuprofen 200mg +
20 Tablet Analgesic
Paracetamol 500mg
Ibuprofen Oro Dispersible
21 Tablet Analgesic
200mg

22 Levetiracetam 250mg Tablet Antiepileptic

23 Levetiracetam 500mg Tablet Antiepileptic

24 Levetiracetam 1000mg Tablet Antiepileptic

25 Loperamide 2mg Capsule Anti diarrhoea/ IBS

Metformin 1000mg ER +
26 Tablet Anti diabetic
Sitagliptin 50mg
Metformin 1000mg ER +
27 Tablet Anti diabetic
Sitagliptin 100mg
Metformin 500mg ER +
28 Tablet Anti diabetic
Sitagliptin 50mg

29 Naproxen sodium 220mg Tablet Analgesic

30 Naproxen sodium 275mg Tablet Analgesic

31 Pregabalin 25mg Capsule Anti neuropathic pain

32 Pregabalin 75mg Capsule Anti neuropathic pain

33 Pregabalin 150mg Capsule Anti neuropathic pain

34 Pregabalin 300mg Capsule Anti neuropathic pain

Promethazine hydrochloride
35 Tablet Antiemetic
10mg

Promethazine hydrochloride
36 Tablet Antiemetic
25mg

37 Rosuvastatin 10mg Tablet Lipid lowering agent

38 Rosuvastatin 20mg Tablet Lipid lowering agent

39 Rosuvastatin 40mg Tablet Lipid lowering agent

40 Sitagliptin 50mg Tablet Anti diabetic

41 Sitagliptin 100mg Tablet Anti diabetic

42 Telmisartan 40mg Tablet Antihypertensive

43 Telmisartan 80mg Tablet Antihypertensive

Benign prostatic hyperplasi
44 Alfuzosin ER 10mg Tablet

Ibuprofen Oro Dispersible

45 Tablet Analgesic
200mg

Simvastatin 20mg +
46 Tablet Anti diabetic
Ezetimibe 10mg
Simvastatin 40mg +
47 Tablet Anti diabetic
Ezetimibe 10mg
48 Sildenafil 50mg Tablet Erectile dysfunction
49 Sildenafil 100mg Tablet Erectile dysfunction
50 Tadalafil 20mg Tablet Erectile dysfunction
 Dossier Available

Regulatory & BE Status Available Pack size

OTC in Australia No BE planned 28's

OTC in Australia Commercially supply to Australia

4x25's
No BE planned

OTC in Australia Commercially supplied to Australia

10's
No BE planned

OTC (high risk) in Australia Commercially supplied to Australia 10's

OTC (high risk) in Australia Commercially supplied to Australia

BE performed for this strength against 10's
Australia RLD

Prescription medicine in Malaysia and Australia 10's

OTC in Australia Commercially supplied in Australia 203,090,200

Prescription medicine
10,30,56 & 100
BE study performed with Europe RLD

Prescription medicine in Australia No BE planned 10's

OTC in Australia No BE planned 10's

OTC in Australia No BE planned 10's

Prescription (Rx) medicine 10's

Prescription (Rx) medicine

Therapeutic medicine in ROW markets No BE planned 10's

OTC in Australia Commercially supplied to Australia &

10's
Nepal

OTC in Australia Commercially supplied to Australia &

Nepal 10's
No BE planned

OTC in Australia 10's

OTC in Australia No BE planned 10's

 OTC in Australia Commercially supplied to Australia
12's
No BE planned

OTC in Australia No BE planned 10's

10's

10's

Prescription medicine in Australia Commercially supplied in Australia

10's
BE study is completed with Europe RLD

10's

OTC in Australia No BE planned 10's

10's
Prescription medicine in Australia as well as all ROW countries.
BE studies has been completed against Swiss RLD for each individual 10's
strength
10's

OTC in Australia 10's

OTC in Australia 10's

10's

Prescription Medicine in Australia Commercially supplied to Nepal & 10's

Philippines
No BE planned 10's

10's

OTC in Australia Commercially supplied to Australia 25's

OTC in Australia Commercially supplied to Australia and

Nepal 25's
No BE planned

10's

Therapeutic medicine (Rx) in all ROW countries

10's
No BE planned

10's

10's
Therapeutic medicine (Rx) in all ROW countries
No BE planned
 Therapeutic medicine (Rx) in all ROW countries
No BE planned
10's

10's
Therapeutic medicine (Rx) in all ROW countries
No BE planned
10's

Prescription medicine Approved and commercially supplied in

10's
Guatemala

OTC in Australia 10's

Prescription medicine Commercially supplied to Guatemala and

10's
Honduras
Prescription medicine Commercially supplied to Guatemala and
10's
Honduras No BE planned
Prescription medicine 10's
Prescription medicine 10's
Prescription medicine Commercially supplied to Peru 4's
Shelf Life (in Months) MOQ/ Batch Size

24 650,000

36 850,000

30 550,000

36 420,000

36 640,000

24 600,000

30 1,000,000

24 1,000,000

24 200,000

24 600,000

24 600,000

24 500,000

24 1,000,000

36 1,060,000

36 450,000

24 800,000

24 800,000
36 1,020,000

24 500,000

24 600,000

36 500,000

36 320,000

36 215,000

24 800,000

24 300,000

24 300,000

24 500,000

24 1,000,000

24 1,000,000

24 1,000,000

36 1,000,000

36 1,000,000

24 1,000,000

30 1,250,000

30 620,000

24

Commen Blend (6 lacs

24
Tablets)

24

24
Commen Blend (10 lacs Tablets)
 Commen Blend (10 lacs Tablets)
24

24 1,000,000

24 600,000

36 1,000,000

24 600,000

24 1,000,000

24 1,000,000

24 600,000
24 600,000
24 600,000
 Dossier under preparat
Dosage By when the complete dossier
S.No Product Name
Form and samples will be available
1 Bosentan 62.5mg / 125mg Tablet Bosentan 62.5 mg dossier will be
ready by April 2024 & 125 mg
not available

Dossier will be ready by

2 Esomeprazole MUPS 20mg Tablet
November 2024,

Dossier will be ready by

3 Esomeprazole MUPS 40mg Tablet
November 2024

Mesalazine 1200mg (Gastro- resistant, Dossier will be ready by

4 Tablet
Prolonged release) December 2024

Dossier will be ready by

5 Mesalamine 500mg (gastro- resistant) Tablet
September 2024

Dossier will be ready by

6 Rifaximin 550mg Tablet
September 2024
Dossier under preparation
Available Pack
Regulatory & BE Status Shelf Life (in Months)
size

Prescription medicine No BE planned 10's 24

Prescription medicine in Australia 10's 24

Prescription medicine in Australia

BE study will be performed against Europe 10's 24
RLD
Prescription Medicine
BE study is performed with Europe RLD in the 12's 24
month of November 24
Prescription medicine
BE study is performed with Europe RLD in the month of 10's 24
August 2024
Prescription medicine
BE study is performed against Europe RLD in the month 10's 24
of July 2024
MOQ/ Batch Size

600000/500000

600,000

600,000

300,000

600,000

500,000
 Products Under Pipeline
S.No Product Name Dosage Form

1 Azithromycin 250mg / 500mg Tablet

2 Aspirin Chewable 300mg Tablet

3 Carbamazepine CR 200mg Tablet

Cinacalcet hydrochloride 30mg / 60mg /

4 120mg Tablet

5 Celecoxib 200mg Capsule

6 Dimethyl Fumarate GR 120mg / 240mg Capsules

7 Doxylamine succinate 25mg Tablet

8 Eletriptan hydrobromide 40mg Tablet

9 Etoricoxib 30mg / 60mg / 90mg / 120mg Tablet

Ferrous sulphate ER 325mg + Sodium

10 Tablet
ascorbate 562.4mg

11 Gabapentin 600mg / 800mg Tablet

12 Ibuprofen Lysine 342mg Tablet

13 Iron Polymaltose 370mg Tablet

14 Losartan Potassium 50mg Tablet

Losartan potassium 50mg +

15 Tablet
Hydrochlorothiazide 12.5mg

16 Mesalamine PR 1g, 2g, 3g Granules

17 Montelukast sodium 10mg Tablet

18 Orlistat 60mg / 120mg Capsule

19 Pregabalin SR 165mg / 330mg Tablet

Quetiapine Fumarate 25mg / 100mg

20 Tablet
/ 150mg / 200mg / 300mg

21 Rifaximin 200mg Tablet

22 Ticagrelor 90mg Tablet

23 Ursodeoxycholic acid 250mg Capsule

24 Voriconazole 50mg / 500mg Tablet

 Products Under Pipeline
Regulatory & BE Status
Available Pack size Shelf Life (in Months)

Prescription medicine
BE study will be planned on completion of product 10's 24
development

OTC in Australia 10's 24

Prescription medicine
BE study will be planned on completion of product 10's 24
development
Prescription medicine
BE study will be planned on completion of product 10's 24
development
Therapeutic medicine in all countries BE study will
10's 24
be performed if required
Prescription medicine
BE study will be planned on completion of product 10's 24
development

OTC in Australia 10's 24

Prescription medicine
6's 24
BE study will be performed if required
Prescription medicine
10's 24
BE study will be performed if required
Registered complementary medicine in Australia.
30's 24
BE study to be planned
Prescription medicine
10's 24
BE study will be performed if required

OTC in Australia 10's 24

Registered complementary medicine in Australia 10's 24

Therapeutic medicine in all ROW markets 10's 24

Therapeutic medicine in all ROW markets 10's 24

Prescription medicine BE study to be planned 60's 24

Prescription medicine
10's 24
BE study will be performed if required
 Prescription medicine
10's 24
BE study will be performed if required

Prescription medicine 30's 24

Prescription medicine
10's 24
BE study will be performed if required

Prescription medicine 10's 24

Prescription medicine BE study to be planned 10's 24

Prescription medicine
10's 24
BE study will be performed if required
Prescription medicine
10's 24
BE study will be performed if required
MOQ/ Batch Size

800000/400000

800,000

600,000

600,000

1,000,000

600,000

400,000

800,000

600,000

1,000,000

800,000

900,000
 1,000,000

600000/400000

500,000

600,000

1,000,000