EU CTD Dossier & Approved Marketing Authorizations
| Sr. No. | Generic Name | Strength | Dosage Form | Therapeutic Category |
|---|---|---|---|---|
|
1 |
Rivaroxaban Tablets
|
10 mg,
|
Film coated Tablets &
|
Anti- Coagulant
|
|
2 |
Rivaroxaban Tablets
|
15mg, |
Film coated Tablets &
|
Anti- Coagulant |
|
3 |
Rivaroxaban Tablets
|
20mg
|
Film coated Tablets &
|
Anti- Coagulant
|
|
4 |
Ibuprofen 400mg Soft Gel Capsule
|
400 mg
|
Soft Gel Capsules
|
NSAID
|
|
5 |
Esomeprazole MUPS
|
20 mg
|
MUPS Tablets
|
Proton Pump Inhibitor
|
|
6 |
Esomeprazole MUPS
|
40 mg
|
MUPS Tablets
|
Proton Pump Inhibitor
|
|
7 |
Lansoprazole capsule
|
15 mg
|
Capsule with EC Pellets
|
Proton-pump inhibitor
|
|
8 |
Lansoprazole capsule
|
30 mg
|
Capsule with EC Pellets
|
Proton-pump inhibitor
|
|
9 |
Montelukast Chewable tablets
|
4mg
|
Chewable tablets
|
Bronchodilator
|
|
10 |
Montelukast Chewable tablets
|
5mg
|
Chewable tablets
|
Bronchodilator
|
|
11 |
Montelukast tablets
|
10mg
|
Chewable tablets
|
Bronchodilator
|
|
12 |
Fluoxetine Capsule
|
20mg
|
Capsule
|
Antidepressant |
|
13 |
Terbinafine Tablet
|
250mg
|
Tablets
|
Antifungal
|
|
14 |
Itraconazole Capsules with Pellets
|
100 mg
|
Capsules with Pellets
|
Antifungal
|
|
15 |
Quetiapine ER tablets
|
50 mg
|
Extended-Release
|
Antipsychotic
|
|
16 |
Quetiapine ER tablets
|
200 mg
|
Extended-Release
|
Antipsychotic
|
|
17 |
Quetiapine ER tablets
|
300 mg
|
Extended-Release
|
Antipsychotic
|
|
18 |
Quetiapine ER tablets
|
400 mg
|
Extended-Release
|
Antipsychotic
|
|
19 |
Pantoprazole 20mg Enteric Coated Tablet
|
20 mg
|
Enteric Coated Tablets
|
Proton-pump inhibitor
|
|
20 |
Pantoprazole 40 mg Enteric Coated Tablet
|
40 mg
|
Enteric Coated Tablets
|
Proton-pump inhibitor
|
|
21 |
Irbesartan Tablets
|
75 mg
|
Tablets
|
Antihypertensive
|
|
22 |
Irbesartan Tablets
|
150mg
|
Tablets
|
Antihypertensive
|
|
23 |
Irbesartan Tablets
|
300 mg
|
Tablets
|
Antihypertensive
|
|
24 |
Ciprofloxacin Film Coated Tablet
|
250 mg
|
Flim Coated Tablets
|
Anti infective
|
|
25 |
Ciprofloxacin Film Coated Tablet
|
500mg
|
Flim Coated Tablets
|
Anti infective
|
|
26 |
Ciprofloxacin Film Coated Tablet
|
750mg
|
Flim Coated Tablets
|
Anti infective
|
|
27 |
Lisinopril Tablet
|
5 mg
|
Tablets
|
ACE inhibitor
|
|
28 |
Lisinopril Tablet
|
10 mg
|
Tablets
|
ACE inhibitor
|
|
29 |
Lisinopril Tablet
|
20 mg
|
Tablets
|
ACE inhibitor
|
|
30 |
Sildenafil Coated tablet
|
25 mg
|
Coated Tablets
|
(PDE) inhibitors
|
|
31 |
Sildenafil Coated tablet
|
50 mg
|
Coated Tablets
|
(PDE) inhibitors
|
|
32 |
Sildenafil Coated tablet
|
100 mg
|
Coated Tablets
|
(PDE) inhibitors
|
|
33 |
Donepezil Film Coated Tablet
|
5 mg
|
Flim Coated Tablets
|
Cholinesterase inhibitors/Alzheimer’
|
|
33 |
Donepezil Film Coated Tablet
|
10 mg
|
Flim Coated Tablets
|
Cholinesterase inhibitors/Alzheimer’
|
|
34 |
Donepezil Film Coated Tablet
|
10 mg
|
Flim Coated Tablets
|
Cholinesterase inhibitors/Alzheimer’
|
|
35 |
Omeprazole Capsule with EC Pellets |
20mg |
Capsule with EC Pellets |
Proton-pump inhibitor/Antacid |
|
36 |
Ceftriaxone
|
1g
|
Powder for solution for injection
|
Antibiotic
|
|
37 |
Ceftriaxone
|
2g
|
Powder for solution for injection
|
Antibiotic
|
|
38 |
Olanzapine Coated tablet
|
2.5 mg
|
Coated Tablets
|
Coated Tablets
|
|
39 |
Olanzapine Coated tablet
|
5 mg
|
Coated Tablets
|
Antipsychotic
|
|
40 |
Olanzapine Coated tablet
|
7.5 mg
|
Coated Tablets
|
Antipsychotic
|
|
41 |
Olanzapine Coated tablet
|
10 mg
|
Coated Tablets
|
Antipsychotic
|
|
42 |
Olanzapine Coated tablet
|
15 mg
|
Coated Tablets
|
Antipsychotic
|
|
43 |
Risedronate Film Coated Tablet
|
5 mg
|
Flim Coated Tablets
|
Bisphosphonates
|
|
44 |
Risedronate Film Coated Tablet
|
30 mg
|
Flim Coated Tablets
|
Bisphosphonates
|
|
45 |
Risedronate Film Coated Tablet
|
35 mg
|
Flim Coated Tablets
|
Bisphosphonates
|
|
46 |
Alendronic Acid Tablet
|
70 mg
|
Tablets
|
Bisphosphonates
|
|
47 |
Lovastatin Tablet
|
20 mg
|
Tablets
|
Statin/Cholesterol
|
|
48 |
Pregabalin Capsule
|
25mg
|
Capsule
|
Neuropathic Pain
|
|
49 |
Pregabalin Capsule
|
75mg
|
Capsule
|
Neuropathic Pain
|
|
50 |
Pregabalin Capsule
|
100 mg
|
Capsule
|
Neuropathic Pain
|
|
51 |
Pregabalin Capsule
|
150mg
|
Capsule
|
Neuropathic Pain
|
|
52 |
Pregabalin Capsule
|
200mg
|
Capsule
|
Neuropathic Pain
|
|
53 |
Pregabalin Capsule
|
225mg
|
Capsule
|
Neuropathic Pain
|
|
54 |
Pregabalin Capsule
|
300mg
|
Capsule
|
Neuropathic Pain
|
|
55 |
Sodium Picosulfate + Magnesium Oxide + Citric Acid Powder (RLD: Picosalax)
|
10 mg+ 3.5 g+ 12g
|
Powder for Oral Solution
|
Stimulant Laxative
|
|
56 |
Ticagrelor Tablet
|
60mg
|
Film coated tablet
|
Antiplatelet
|
|
57 |
Ticagrelor Tablet
|
90 mg
|
Film coated tablet
|
Antiplatelet
|
|
58 |
Linagliptin Tablet
|
5mg
|
Tablet
|
Antidiabetic
|
|
59 |
Ceftazidime
|
1gm
|
Powder for solution for injection
|
Antibiotic
|
|
60 |
Ceftazidime
|
2gm
|
Powder for solution for injection
|
Antibiotic
|
|
61 |
Apixaban
|
2.5 mg
|
Film coated Tablets
|
Anti- Coagulant
|
|
62 |
Apixaban
|
5mg
|
Film coated Tablets
|
Anti- Coagulant
|
EU CTD Dossier & Marketing Authorizations : Filed
| Sr. No. | Generic Name | Strength | Dosage Form | Therapeutic Category |
|---|---|---|---|---|
|
1 |
Fosfomycin Tromethamine
|
(Equivalent to Fosfomycin 3gm)
|
Powder for Oral Solution
|
Treatment of UTI
|
|
2 |
Cefepime
|
1g
|
Powder for solution for injection
|
Antibiotic
|
|
3 |
Cefepime
|
2g
|
Powder for solution for injection
|
Antibiotic
|
|
4 |
Sitagliptin + Metformin IR tab
|
50/500 mg
|
Immediate Release Tablets
|
Anti- hyperglycaemic agents
|
|
5 |
Sitagliptin + Metformin IR tab
|
50/1000 mg
|
Immediate Release Tablets
|
Anti- hyperglycaemic agents
|
|
6 |
Sacubitril + Valsartan
|
50mg
|
Tablet
|
Cardiovascular agent
|
|
7 |
Sacubitril + Valsartan
|
100mg
|
Tablet
|
Cardiovascular agent
|
|
8 |
Sacubitril + Valsartan
|
200mg
|
Tablet
|
Cardiovascular agent
|
|
9 |
Paracetamol infusion
|
10 mg/ml
|
Solution
|
Analgesic and Antipyretic
|
|
10 |
Paracetamol Effervescent Tablets
|
500mg
|
Effervescent Tablets
|
Analgesic and Antipyretic
|
|
11 |
Paracetamol Granules
|
150 mg
|
Powder for oral solution
|
Analgesic and Antipyretic
|
EU CTD Dossier & Marketing Authorizations : Under Filing
| Sr. No. | Generic Name | Strength | Dosage Form | Therapeutic Category |
|---|---|---|---|---|
|
1 |
Guanfacine ER tab
|
1mg
|
Extended-Release Tablets
|
ADHD
|
|
2 |
Guanfacine ER tab
|
2mg
|
Extended-Release Tablets
|
ADHD
|
|
3 |
Guanfacine ER tab
|
3mg
|
Extended-Release Tablets
|
ADHD
|
|
4 |
Guanfacine ER tab
|
4mg
|
Extended-Release Tablets
|
ADHD
|
|
5 |
Empagliflozin Tablets
|
10 mg
|
Immediate Release Tablets
|
Anti- hyperglycaemic agents
|
|
6 |
Empagliflozin Tablets
|
25 mg
|
Immediate Release Tablets
|
Anti- hyperglycaemic agents
|
|
7 |
Cefuroxime
|
750mg
|
Powder for solution for injection
|
Antibiotic
|
|
8 |
Cefuroxime
|
1.5 g
|
Powder for solution for injection
|
Antibiotic
|
|
9 |
Cefoperazone
|
1g
|
Powder for solution for injection
|
Antibiotic
|
|
10 |
Cefoperazone
|
2g
|
Powder for solution for injection
|
Antibiotic
|
|
11 |
Cefotaxime
|
1g
|
Powder for solution for injection
|
Antibiotic
|
|
12 |
Cefotaxime
|
2g
|
Powder for solution for injection
|
Antibiotic
|
|
13 |
Sitagliptin + Metformin XR tab
|
50/500 mg
|
Modified Release Tablets
|
Anti-hyperglycaemic
|
|
14 |
Sitagliptin + Metformin XR tab
|
50/1000 mg
|
Modified Release Tablets
|
Anti-hyperglycaemic
|
|
15 |
Sitagliptin + Metformin XR tab
|
100/1000 mg
|
Modified Release Tablets
|
Anti-hyperglycaemic
|
|
16 |
Clotrimazole Vaginal tablets
|
500mg
|
tablets
|
Treatment of vaginal yeast infections
|
|
17 |
Linagliptin + Metformin Tablet
|
2.5mg+850mg
|
tablets
|
Antidiabetic
|
|
18 |
Linagliptin + Metformin Tablet
|
2.5mg+1000mg
|
tablets
|
Antidiabetic
|
|
18 |
Dapagliflozin + Metformin Tablet
|
5mg+850mg
|
tablets
|
Antidiabetic
|
|
20 |
Dapagliflozin + Metformin Tablet
|
5mg+1000mg
|
tablets
|
Antidiabetic
|
|
21 |
Co-amoxiclav Tablets 625 mg
|
500mg+125mg
|
tablets
|
Antibiotic
|
|
22 |
Co-amoxiclav Tablets 1000mg
|
875mg+125mg
|
tablets
|
Antibiotic
|
|
23 |
Co-amoxiclav Tablet 375mg
|
250mg+125mg
|
tablet
|
Antibiotic
|
|
24 |
Naproxen 500mg+Esomeprazole 20mg Tablet
|
500mg+20mg
|
tablets
|
Anti-Inflammatory
|
|
25 |
Sevelamer Carbonate
|
0.8gm
|
Powder for Oral Solution
|
Treatment of hyperphosphatemia
|
|
26 |
Sevelamer Carbonate
|
2.4gm
|
Powder for Oral Solution
|
Treatment of hyperphosphatemia
|
|
27 |
Anastrozole
|
1 mg
|
Film-Coated Tablet
|
Antineoplastic (Hormonal Therapy – Aromatase Inhibitor)
|
|
28 |
Azacitidine
|
100 mg
|
Injection
|
Antineoplastic (Antimetabolite – Hypomethylating Agent)
|
|
29 |
Bendamustine
|
25 mg
|
Injection
|
Antineoplastic (Alkylating Agent)
|
|
30 |
Bendamustine
|
100 mg
|
Injection
|
Antineoplastic (Alkylating Agent)
|
|
31 |
Carboplatin Injection
|
150 mg / 15 mL
|
Injection
|
Antineoplastic (Platinum Compound)
|
|
32 |
Carboplatin Injection
|
450 mg / 45 mL
|
Injection
|
Antineoplastic (Platinum Compound)
|
|
33 |
Carmustine
|
100 mg
|
Powder + Solvent for Infusion
|
Antineoplastic (Nitrosourea Alkylating Agent)
|
|
34 |
Cisplatin
|
50 mg / 50 mL
|
Concentrate for Infusion
|
Antineoplastic (Platinum Compound)
|
|
35 |
Imatinib
|
100 mg
|
Film-Coated Tablet
|
Antineoplastic (Tyrosine Kinase Inhibitor – TKI)
|
|
36 |
Imatinib
|
400 mg
|
Film-Coated Tablet
|
Antineoplastic (Tyrosine Kinase Inhibitor – TKI)
|
|
37 |
Letrozole
|
2.5 mg
|
Tablet
|
Antineoplastic (Hormonal Therapy – Aromatase Inhibitor)
|
|
38 |
Melphalan
|
50 mg
|
Powder for Injection/Infusion
|
Antineoplastic (Alkylating Agent)
|
|
39 |
Thiotepa
|
15 mg
|
Powder for Infusion
|
Antineoplastic (Alkylating Agent)
|
|
40 |
Thiotepa
|
100 mg
|
Powder for Infusion
|
Antineoplastic (Alkylating Agent)
|