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Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

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Page 1: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen
Page 2: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen
Page 3: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen
Page 4: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

ANALGESICS / ANTIPYRETICS / ANTIARTHRITICS

SL. NO

PRODUCTS COMPOSITION

1 BALGESIC TABLETS Each film coated tablet contains : Aceclofenac 100 mg

2 BALGESIC PLUS TABLETS Each film coated tablet contains : Aceclofenac 100 mg Paracetamol IP 325 mg

3 BALNAC 50 TABLETS Each enteric coated tablet contains : Diclofenac Sodium BP 25 mg / 50 mg

4 BUSOBAN TABLETS Each sugar coated tablet contains : Hyoscine Butyl Bromide BP

10 mg

5 BALFEN TABLETS Each film coated tablet contains : Ibuprofen BP 200 mg / 400 mg / 600 mg

6 COMBIGESIC DP TABLETS Each film coated tablet contains : Diclofenac Sodium BP 50 mg (as enteric coated granules), Paracetamol BP 500 mg

7 COMBIGESIC PLUS

TABLETS

Each uncoated Bilayered tablets contains : Paracetamol BP 500

mg, Diclofenac Sodium BP 50 mg

8 REGAMOL EXTRA Each uncoated tablets contains : Paracetamol BP 500 mg, Caffeine BP 30 mg

9 INDOBID CAPSULES Each capsule contains : Indomethacin BP 25 mg

10 LOFEN GEL Diclofenac Diethylamine BP 1.16% w/w equivalent to Diclofenac sodium BP 1% w/w

11 LOFEN PLUS GEL Diclofenac Diethyl amine B.P 1.16% w/w eq to Diclofenac Sodium 1% w/w, Linseed oil BP 3% w/w Methylsalicylate USP 10% w/w

12 MEFDOL CAPSULES Each capsules contains : Mefenamic Acid BP 250 mg

13 MEFDOL FORTE TABLETS Each uncoated tablet contains : Mefenamic Acid BP 500 mg

14 MELOXI TABLETS Each uncoated tablet contains : Meloxicam BP 7.5 mg / 15 mg

15 MONOGESIC TABLETS Each uncoated tablet contains : Nimesulide BP 100 mg

16 MONOGESIC PLUS TABLETS

Each uncoated tablet contains : Nimesulide BP 100 mg, Paracetamol BP 500 mg

17 MONOGESIC DT TABLETS Each uncoated disperable tablet contains :Nimesulide BP 100 mg

18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg

19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen BP 400 mg, Paracetamol BP 325 mg

20 BIBUCIN CAPSULES Each capsule contains : Ibuprofen BP 200 mg, Paracetamol BP 325 mg, Caffeine(anhydrous) BP 30 mg

21 REGAMOL 500 TABLETS Each uncoated tablet contains : Paracetamol BP 500 mg

22 REGAMOL 650 TABLETS Each uncoated tablet contains : Paracetamol BP 650 mg

23 REGAMOL SYRUP Each 5 ml contains : Paracetamol BP 125 mg

Page 5: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

ANALGESICS / ANTIPYRETICS / ANTIARTHRITICS

SL. NO

PRODUCTS COMPOSITION

24 ROXICAM CAPSULES Each capsule contains : Piroxicam USP 10 mg / 20 mg

25 ROXICAM DT TABLETS Each uncoated dispersible tablet contains : Piroxicam USP 20 mg

26 ROXIGEL Piroxicam BP 0.5 % w/w in a water soluble base

27 BALDOL Each capsule contains : Tramadol Hydrochloride BP 50 mg

ANTACIDS / ANTIULCERANTS / ANTIEMETICS / ANTISPASMODICS

SL. NO

PRODUCTS COMPOSITION

1 BAL-LANZ CAPSULES Each capsule contains : Lansoprazole USP 30 mg (as enteric coated granules)

2 OMEP CAPSULES Each capsule contains : Omeprazole BP 20 mg (as enteric coated granules)

3 RANCER TABLETS Each film coated tablet contains : Ranitidine Hcl USP equivalent to Ranitidine 150 mg / 300 mg

4 DOMTIL TABLETS Each uncoated tablet contains :Domperidone BP 10 mg

5 SILIDROX SUSPENSION Each 10 ml contains : Sodium Alginate BP 200 mg, Dried Aluminium Hydroxide Gel BP 300 mg, Magnesium Trisilicate BP 125 mg

6 PANTOFIX TABLETS Each enteric coated tablet contains : Pantoprazole Sodium USP (Sesquihydrate) equ. To Pantoprazole 20 mg / 40 mg

7 RABIFIX - 20 Each enteric coated tablet contains : Rabeprazole Sodium 20 mg

ANTI HISTAMINE / ANTIALLERGICS

SL. NO

PRODUCTS COMPOSITION

1 UNICET TABLETS Each film coated tablet contains : Cetirizine Hydrochloride BP 10 mg

2 BAL-LORA TABLETS Each uncoated dispersible tablet contains : Loratadine USP 10 mg

3 BAL-RIACTIN TABLETS Each uncoated tablet contains : Cyproheptadine Hcl BP (Anhydrous) 4 mg

4 BAL-RIACTIN SYRUP Each 5 ml Contains : Cyproheptadine Hcl (Anhydrous) 2 mg

5 EBAY TABLETS Each film coated tablet contains : Ebastine BP 10 mg

6 LEOCET Each film coated tablet contains : Levocetirizine Dihydrochloride BP 5 mg

Page 6: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

ANTIBIOTIC / ANTIBACTERIAL

SL. NO

PRODUCTS COMPOSITION

1 AZIWIN TABLETS Each film coated tablet contains : Azithromycin Dihydrate USP

equivalent to Azithromycin 250 mg / 500 mg

2 AZIWIN 100 DT TABLETS Each dispersible tablet contains : Azithromycin Dihydrate USP equivalent to Azithromycin 100 mg

3 AZIWIN (FOR READY USE SUSPENSION)

Each 5 ml of Suspension contains : Azithromycin USP 100/200mg (as Azithromycin Dihydrate)

4 ERYCIN TABLETS Each film coated tablet contains : Erythromycin Stearate BP equivalent to Erythromycin 250 mg / 500 mg

5 BALTRIM TABLETS Each uncoated tablet contains : Sulphamethoxazole BP 400 mg, Trimethoprim BP 80 mg

6 BALTRIM FORTE TABLETS

Each uncoated tablet contains : Sulphamethoxazole BP 800 mg, Trimethoprim BP 160 mg

7 BALTRIM SUSPENSION Each 5 ml contains : Sulphamethoxazole BP 200 mg, Trimethoprim BP 40 mg

8 BALDOX CAPSULES Each capsules contains : Doxycycline Hcl BP equivalent to Doxycycline 100 mg

9 REGACYCLINE CAPSULES

Each capsule contains : Tetracycline Hcl BP 250 mg / 500 mg

10 ROX TABLETS Each film coated tablet contains : Roxithromycin BP 150 mg

11 ULTRAFLOX TABLETS Each film coated tablet contains : Ciprofloxacin Hcl USP equivalent to Ciprofloxacin USP 250 mg / 500 mg

12 ZANOVID TABLETS Each film coated tablet contains : Oflaxacin USP 200 mg

13 UFLOX TABLETS Each film coated tablet contains : Norfloxacin BP 400 mg

BETA-LACTAMS

SL. NO

PRODUCTS COMPOSITION

1 ACILLIN CAPSULES Each capsule contains : Ampicillin Trihydrate BP equivalent to Ampicillin 250 mg / 500 mg

2 DYNAMOX KID TABLETS Each tablet contains : Amoxicillin Trihydrate BP equivalent to Amoxicillin 125 mg

3 DYNAMOX-250 DT TABLETS

Each uncoated dispersible tablet contains : Amoxicillin Trihydrate BP equivalent to Amoxicillin 250mg

4 DYNAMOX CAPSULES Each capsule contains : Amoxicillin Trihydrate BP equivalent to Amoxicillin 250 mg / 500 mg

5 DYNAMOX DRY SUSPENSION

Each 5ml of Reconstituted Suspension Contains : Amoxicillin Trihydrate BP equivalent to Amoxicillin 125 mg / 250 mg

Page 7: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

CEPHALOSPORINS

SL. NO

PRODUCTS COMPOSITION

1 BALTAX INJECTION

Each composite pack contains A & B Each vial contains : A) Cefatoxime Sodium USP equivalent to Cefatoxime 500 mg / 1g B) One ampoule containing 5ml Sterile Water for Injection BP

2 ZENTRIAX INJECTION

Each composite pack contains A & B Each vial contains : A) Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg / 1 gm B) One ampoule containing 10ml Sterile Water for Injection BP

ANTITUBERCULAR

SL. NO

PRODUCTS COMPOSITION

1 BALBUTOL TABLETS Each uncoated tablet contains : Ethambutol Hcl BP 200 mg / 400

mg

2 BALZID TABLETS Each film coated tablet contains : Rifampicin BP 300 mg, Isoniazid BP 150 mg

3 BALZID-KID TABLETS Each uncoated tablet contains : Rifampicin BP 150 mg, Isoniazid BP 100 mg

4 RZID-DT TABLETS Each uncoated dispersible tablet contains : Rifampicin BP 100 mg,

Isoniazid BP 100 mg

5 RZID TABLETS Each film coated tablet contains : Rifampicin BP 450 mg, Isoniazid BP 300 mg

6 RIFAMBTER TABLETS Each sugar coated tablet contains : Rifampicin BP 120 mg, Isoniazid BP 80 mg, Pyrazinamide BP 250 mg

7 RIFAMPICIN SUSPENSION

Each 5 ml of reconstituted suspension contains : Rifampicin BP 100 mg

8 RIFACAP CAPSULES Each capsule contains : Rifampicin BP 150 mg / 300 mg

ANTHELMINTICS / ANTIPROTOZOALS

SL. NO

PRODUCTS COMPOSITION

1 ALZOL TABLETS Each uncoated tablet contains : Albendazole USP 200 mg / 400 mg.

2 BALGYL TABLETS Each tablet contains : Metronidazole BP 200 mg / 250 mg / 400 mg / 500 mg

3 BALGYL SUSPENSION Each 5 ml contains : Metronidazole benzoate BP 200 mg, equivalent to Metronidazole 125 mg

4 BALFLOX TD TABLETS Each film coated tablet contains : Norfloxacin BP 400 mg, Tinidazole BP 600 mg

5 BALTIN TABLETS Each film coated tablet contains :Tinidazole BP 300 mg / 500 mg

Page 8: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

ANTIMICROBIAL ORAL

SL. NO

PRODUCTS COMPOSITION

1 FLUCONAZOLE CAPSULES

Each capsule contains : Fluconazole USP 50 mg / 100 mg / 150 mg / 200 mg

2 GRISORAL TABLETS Each uncoated tablet contains : Griseofulvin BP 125/250/500 mg

3 KETOVATE TABLETS Each uncoated tablet contains : Ketoconazole USP 200 mg

ANTIMICROBIAL TOPICAL

SL. NO

PRODUCTS COMPOSITION

1 BALVIDINE OINTMENT Povidone Iodine USP 5% w/w, 7.5% w/w, 10% w/w

2 BALVIDINE SOLUTION Povidone Iodine Solution USP 5%, 7.5%, 10% w/v

3 SILVERINE CREAM Silver Sulphadiazine USP 1% w/w

4 CANDIZOLE CREAM Miconazole Nitrate BP 2% w/w

5 CORTIDERM CREAM Betamethasone Dipropionate USP equivalent to Betamethasone 0.05% w/w in a cream base

6 CORTIDERM-S Betamethasone Dipropionate USP equivalent to Betamethasone 0.05% w/w, Salicyclic Acid BP 3% w/w in a cream base

7 CORTIDERM-G CREAM Betamethasone Dipropionate USP eq. to Betamethasone USP 0.05 % w/w Gentamicin Sulphate I.P. eq. to Gentamicin

0.1 % w/w in a cream base

8 CORTIDERM-GM CREAM Betamethasone Dipropionate USP equivalent to Betamethasone 0.05% w/w, Gentamicin sulphate IP equivalent to Gentamicin 0.1%w/w, Miconazole Nitrate IP 2% w/w in a cream base

9 CORTIDERM-N CREAM Betamethasone Dipropionate USP equivalent to Betamethasone 0.05% w/w, Neomycin Sulphate IP 0.5% w/w in a cream base

10 KETOVATE CREAM Ketoconazole USP 2% w/w in a cream base.

11 KETOVATE SHAMPOO Ketoconazole USP 2.0% w/v

12 REGESTEN CREAM Clotrimazole BP 1% w/w

ANTIMALARIALS

SL. NO

PRODUCTS COMPOSITION

1 BAL QUININE TABLETS Each film coated tablet contains : Quinine Sulphate BP 100 mg / 250 mg / 300 mg / 500 mg

2 PLASMOQUIN TABLETS Each film coated tablet contains : Chloroquine Phosphate BP 250 mg / 100 mg

Page 9: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

VITAMINS / NUTRITIONAL SUPPLEMENTS

SL. NO

PRODUCTS COMPOSITION

1 MANVIT SYRUP (Multivitamin Syrup)

Each 5 ml contains :

Vitamin A (as Palmitate) USP 1000 IU, Thiamine Hcl BP 1.5 mg, Riboflavin Sodium Phosphate BP 1.5 mg, Vitamin B12 BP 2.5 mcg, Vitamin C BP 40 mg, Vitamin D3 BP 200 IU, Niacinamide BP 10 mg

2 BALOFER SYRUP (Iron Tonic)

Each 5ml contains : Iron(III) Hydroxide Polymaltose complex equivalent to Elemental Iron 50 mg, Cyanocobalamin BP 5 mcg

3 BALOFER M SYRUP (Iron Tonic)

Each 5ml contains : Iron(III) Hydroxide Polymaltose complex equivalent to Elemental Iron 10 mg, Cyanocobalamin BP 1.5 mcg

4 BALVITA SYRUP (Multivitamin Syrup with Ginseng)

Each 5 ml contains : Vitamin A (as palmitate) USP 282 IU Thiamine Hcl BP 0.625 mg, Riboflavin Sodium phosphate BP 0.625 mg, Pyridoxine Hcl BP 0.250 mg, Cyanocobalamin BP 0.875 mcg, Ascorbic Acid BP 10 mg, Vitamin D3 BP 45 IU, Niacinamide BP 5.0 mg, D-Panthenol USP 1.25 mg, Ginseng Extract equivalent to root 87.5 mg

5 BALVITA - G SYRUP (Multivitamin Syrup with Ginseng)

Each 5 ml contains : Vitamin A (as palmitate) BP 2000 IU Thiamine Hcl BP 0.9 mg, Riboflavin Sodium phosphate BP 1.1 mg, Pyridoxine Hcl BP 1.1 mg, Cyanocobalamin BP 1.5 mcg, Vitamin D3 BP 400 IU, Niacinamide BP 12 mg, D-Panthenol BP 1.25 mg, Ginseng Extract powder 50 mg

6 HEMOTON - M Syrup (Iron Tonic)

Each 5 ml contains : Ferric Ammonium Cirtate BP equivalent to Elemental Iron 20 mg, Folic Acid BP 0.3 mg, Thiamine Hcl BP 0.9 mg, Pyridoxine Hcl BP 1.1 mg, Niacinamide BP 12 mg

7 CARBOFER Z CAPSULES Each capsule contains : Carbonyl Iron 18 mg, Folic acid BP 0.5 mg,

Zinc Sulphate Monohydrate USP 15 mg

8 GSO4 CAPSULES Each capsule contains : Glucosamine Sulphate Potassium Chloride USP 500 mg

9 GSO4 CART TABLETS Each tablet contains : Glucosamine Sulphate Potassium Chloride USP 500 mg

10 OCIUM TABLETS Each tablet contains : Calcium Carbonate (Organic Oyster shell source) 625 mg equivalent to Elemental Calcium 250 mg, Vitamin D3 BP 125 IU

11 OCIUM 500 TABLETS Each tablet contains : Calcium Carbonate (Organic Oyster shell source) 1250 mg Piroxicam BP 0.5 % w/w in a water soluble base

12 OCIUM-M TABLETS

Each tablet contains : Calcium carbonate (Organic Oyster shell source) 500 mg, Dibasic Calcium phosphate 100 mg (as Dihydrate)

Vitamin D3 BP 200 I.U Magnesium BP 90 mg (as Magnesium Hydroxide), Zinc USP 4 mg (as Zinc Sulphate Monohydrate)

13 OCIUM CHEWABLE TABLETS

Each tablet contains : Calcium Carbonate (Organic Oyster shell source) 625 mg equivalent to Elemental Calcium 250 mg, Vitamin D3 BP 125 IU

14 CITROCIUM TABLETS Each Tablet contains: Calcium Citrate USP 1000mg, Vitamin D3 BP 200 IU

Page 10: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

CARDIAC CARE

SL. NO

PRODUCTS COMPOSITION

1 ALDOSTIX TABLETS Each film coated tablet contains : Frusemide IP 20 mg, Spironolactone IP 50 mg

2 ACLOTIL TABLETS Each film coated tablet contains : Clopidogrel bisulphate USP equivalent to Clopidogrel 75 mg

3 BAL-ASPIRIN TABLETS Each uncoated tablet contains : Acetyl Salicyclic Acid BP 100 mg / 300 mg / 500 mg

4 DIURIX TABLETS Each film coated tablet contains : Indapamide USP 2.5 mg

5 DIURIX SR TABLETS Each film coated sustained release tablet contains : Indapamide USP 1.5 mg

6 LIPOFIX TABLETS Each film tablet contains : Atorvastatin Calcium eq. to Atorvastatin 10 mg / 20 mg / 40 mg

7 LIPOFIX EX TABLETS Each film coated tablet contains : Atrovstatin USP 10 mg, Ezetimibe USP 10 mg

8 SERVACE CAPSULES Each capsule contains : Ramipril BP 1.25mg/2.5 mg/5mg/10mg

9 SERVACE AM CAPSULES Each capsule contains : Amlodipine Besylate equivalent to Amlodipine 5 mg, Ramipril BP 2.5 mg

10 SERVACE H CAPSULES Each capsule contains : Ramipril BP 2.5 mg, Hydrochlorthiazide BP 12.5 mg

12 SIMVOFIX TABLETS Each film coated contains : Simvastatin USP 10 mg / 20 mg / 40 mg

13 AMILOGEN TABLETS Each film coated tablet contains :

Amiloride Hcl BP equivalent to Anhydrous Amiloride Hcl 5 mg

14 MODUGEN TABLETS Each film coated tablet contains : Amiloride Hcl BP equivalent to Anhydrous Amiloride Hcl 5 mg, Hydrochlorthiazide BP 50 mg

15 TELONG TABLETS Each uncoated tablet contains : Telmisartan 20 mg / 40 mg

16 TELONG-H TEBLETS Each uncoated tablet contains: Telmisartan IP 40 mg, Hydrochlorothiazide IP 12.5 mg

17 GLYVAS Each film coated tablet contains: Rosuvastatin Calcium equivalent to Rosuvastatin 5 mg / 10 mg / 20 mg

18 AMLOTUS Each uncoated tablet contains: Amlodipine Besilate BP equivalent to

Amlodipine 2.5 mg / 5 mg / 10 mg

Page 11: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

ANTIDIABETICS

SL. NO

PRODUCTS COMPOSITION

1 DIABEND TABLETS Each uncoated tablet contains : Gliclazide BP 40 mg / 80 mg

2 DIABEND M TABLETS Each uncoated tablet contains : Gliclazide 80 mg, Metformin Hcl 500 mg

3 DIABEND MR TABLETS Each uncoated modified released tablet contains : Gliclazide BP 30 mg / 60 mg

4 DIACON TABLETS Each uncoated tablet contains : Glipizide BP 5 mg

5 DIACON M TABLETS Each uncoated tablet contains : Glipizide 2.5 mg / 5 mg Metformin Hcl 500 mg

6 DIAMET TABLETS Each uncoated tablet contains : Metformin Hcl BP 500 mg / 850 mg

7 DIAMET SR TABLETS Each film coated sustained release tablet contains : Metformin Hcl BP 500 mg / 1000 mg

8 GLUCONIL TABLETS Each uncoated tablet contains : Glibenclamide BP 5 mg

9 PIOREST-M TABLETS

Each uncoated tablet contains :

Metformin Hcl IP 500 mg, Pioglitazone Hcl IP equivalent to Pioglitazone 15 mg

10 GLUCONIL TABLETS Each uncoated tablet contains : Glibenclamide BP 5 mg

11 GLUCONIL M Each uncoated tablet contains :

Glibenclamide BP 5 mg, Metformin Hcl BP 500 mg

12 PIOREST TABLETS Each uncoated tablet contains : Pioglitazone Hcl equivalent to Pioglitazone 15 mg / 30 mg

13 RECARB TABLETS Each film coated tablet contains : Acarbose BP 25 mg / 50 mg

14 SECRETAG TABLETS Each uncoated tablet contains : Glimepride USP 1 / 2 / 3 / 4 mg

15 GLYVOG TABLETS Each uncoated tablet contains : Voglibose IP 0.2 mg / 0.3 mg

16 SECREMET - 1 Each uncoated tablet contains : Glimepiride USP 1 mg, Metformin Hydrochloride USP 500 mg

(As sustained release form)

17 SECREMET - 2 Each uncoated tablet contains : Glimepiride USP 2 mg, Metformin Hydrochloride USP 500 mg (As sustained release form)

Page 12: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

I.V. INFUSIONS

SL. NO

PRODUCTS COMPOSITION

1 DEXTROSE INJECTION

5%, 500ml

Each 100 ml contains :Anhydrous Dextrose USP 5.0 g

Water for Injection USP q.s.

2 GLUCOSE I.V. INFUSION 10%, 500ml

Each 100 ml contains : Anhydrous Glucose BP 10 g Water for Injection BP q.s.

3 GLUCOSE I.V. INFUSION 5%, 500ml

Each 100 ml contains : Anhydrous Glucose BP 5.0 g Water for Injection BP q.s.

4 DEXTROSE INJECTION 10%, 500ml

Each 100 ml contains : Anhydrous Dextrose USP 10 g Water for Injection USP q.s.

5 DEXTROSE & SODIUM CHLORIDE INJECTION, 500ml

Each 100 ml contains : Dextrose Anhydrous USP 5 g, Sodium chloride USP 0.9 g, Water for injection USP q.s

6 GLUCOSE & SODIUM CHLORIDE I.V. INFUSION, 500ml

Each 100 ml contains : Glucose Anhydrous BP 5 g, Sodium chloride BP 0.9 g, Water for injection BP q.s

7 SODIUM CHLORIDE I.V. INFUSION, 500ml

Each 100 ml contains : Sodium Chloride BP 0.9 % w/v Water for Injection BP q.s.

8 COMPOUND SODIUM LACTATE INJECTION (RINGER LACTATE) 500ml

Each 100 ml contains : Lactic Acid BP 0.240 ml, Sodium Hydroxide BP 0.115 g, Sodium Chloride BP 0.600 g, Potassium Chloride BP 0.04 g, Calcium Chloride BP 0.027 g, Water for Injection BP q.s.

9 MANNITOL 10% / 20% I.V.

INFUSION, 350 ml

Each 100 ml contains : Mannitol USP 10 g / 20 g

Water for Injection USP q.s.

10 METRONIDAZOLE I.V. INFUSION, 100ml

Each 100 ml contains : Metronidazole BP 500 mg, Sodium Chloride BP 0.72% w/v, Water for Injection BP q.s.

11 CIPROFLOXACIN INJECTION

Each 100 ml contains : Ciprofloxacin Lactate equivalent to Ciprofloxacin USP 200 mg, Sodium chloride USP 0.9% w/v Water for Injection USP q.s.

12 LEVOFLOXACIN I.V. INFUSION, 100 ml

Each 100 ml contains : Levofloxacin Hemihydrate equivalent to Levofloxacin 500 mg, Water for Injection USP q.s.

13 ORNIDAZOLE I.V. INFUSION, 100 ml

Each 100 ml contains : Ornidazole 500 mg, Sodium Chloride USP 0.9%, Water for Injection USP q.s

14 ORNIDAZOLE & OFLOXACIN I.V. INFUSION, 100 ml

Each 100 ml contains : Ornidazole 500 mg, Ofloxacin USP 200 mg, Sodium Chloride USP 0.9%, Water for Injection USP q.s

15 ORNIDAZOLE & CIPROFLOXACIN I.V. INFUSION, 100 ml

Each 100 ml contains : Ornidazole 500 mg, Ciprofloxacin Lactate Monohydrate equivalent to Ciprofloxacin USP 200mg, Sodium Chloride USP 0.9%,

Water for Injection USP q.s

16 FLUCONAZOLE IV, 100 ml Each 100ml contains : Fluconazole USP 200mg, Sodium Chloride BP 0.9% w/v,

Water for Injection BP q.s.

17 PARACETAMOL IV, 100 ml Each 100ml contains : Paracetamol BP 1 g

Page 13: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

OPHTHALMIC PREPARATIONS

SL. NO

PRODUCTS COMPOSITION

1 BETAXOLOL OPHTHALMIC SOLUTION

Each ml contains : Betaxolol Hcl USP equivalent to Betaxolol USP 0.5% w/v, Benzalkonium chloride solution BP 0.02% w/v, (as preservative), Water for injection BP q.s

2 CHLORAMPHENICOL & DEXAMETHASONE EYE/EAR DROPS

Each ml contains : Dexamethasone BP 0.1%w/v, Chloramphenicol BP 1.0% w/v, Phenyl mercuric nitrate BP 0.001% w/v (as preservative), Water for injection BP q.s

3 CHLORAMPHENICOL EYE DROPS

Each ml contains : Chloramphenicol BP 0.5% w/v, Phenyl

mercuric nitrate BP 0.001% w/v (as preservative), Water for injection BP q.s

4 CIPROFLOXACIN EYE DROPS

Each ml contains : Ciprofloxacin Hcl USP equivalent to Ciprofloxacin USP 3 mg, Benzalkonium chloride sol. USP 0.02% w/w (as preservative), Water for injection USP q.s

5 CYCLOPENTOLATE HCL OPHTHALMIC SOLUTION

Each ml contains :

Cyclopentolate Hcl USP 1.0% w/v, Benzalkonium chloride solution BP 0.02% w/v (as preservative), Water for injection BP q.s

6 DICLOFENAC SODIUM OPHTHALMIC SOLUTION

Each ml contains : Diclofenac Sodium USP 0.1% w.v, Phenyl mercuric nitrate USP 0.001% w/v, (as preservative), Water for injection USP q.s

7 FLURBIPROFEN SODIUM OPHTHALMIC SOLUTION

Each ml contains : Flurbiprofen sodium USP 0.03% w/v, Phenyl mercuric nitrate IP 0.001% w/v (as preservative), Water for injection BP q.s

8 FUNGICON E/E DROPS (FLUCONAZOLE EYE/EAR DROPS)

Each ml contains : Fluconazole USP 0.3% w/v, Benzalkonium chloride solution BP 0.02% w/v, Water for injection BP q.s

9 GENTINA E/E DROPS (GENTAMICIN SULFATE OPHTHALMIC SOLUTION)

Each ml contains :

Gentamicin sulfate BP equivalent to Gentamicin BP 0.3% w/v, Benzalkonium chloride solution BP (as preservative) 0.02% w/v, Hydrochlorthiazide BP 50 mg

10 HYDROXYPROPYL METHYL CELLULOSE EYE DROPS

Each ml contains : Hydroxypropylmethyl BP 0.7% w/v, Borax BP 0.2% w/v, Sodium Chloride BP 0.45% w/v, Boric Acid BP 0.2% w/v, Potassium Chloride BP 0.37% w/v, Benzalkonium chloride solution BP 0.02% w/v, Water for injection BP q.s

11 NAPHAZOLINE HCL OPHTHALMIC SOLUTION

Each ml contains : Naphazoline Hcl USP 0.01% w/v, Benzalkonium chloride solution BP(as preservative) 0.02% w/v, Water for injection BP q.s

12 NORFLOXACIN OPHTHALMIC SOLUTION

Each ml contains : Norfloxacin USP 0.3% w/w, Benzalkonium chloride solution USP (as preservative) 0.02% w/v, Water for injection USP q.s

13 OCULAN EYE DROPS (TIMOLOL MALATE EYE

DROPS)

Each ml contains : Timolol malate BP equivalent to Timolol BP 0.25% w/v / 0.5% w/v

Benzalkonium chloride solution BP (as preservative) 0.02% w/v, Water for injection q.s

14 OFLOXACIN OPHTHALMIC SOLUTION

Each ml contains : Ofloxacin USP 0.3% w/v, Benzalkonium chloride solution BP (as preservative) 0.02% w/v, Water for injection USP q.s

Page 14: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen

OPHTHALMIC PREPARATIONS

SL. NO

PRODUCTS COMPOSITION

1 PILOCARPINE NITRATE OPHTHALMIC SOLUTION

Each ml contains : Pilocarpine Nitrate USP 1.0% w/v, Chlorobutanol USP-NF (as preservative) 0.5% w/v, Water for injection BP q.s

2 TROPICAMIDE EYE DROPS

Each ml contains : Tropicamide BP 1.0% w/v, Phenyl mercuric nitrate BP 0.001% w/v (as preservative),

EXPECTORANT/ANTICOLD

SL. NO

PRODUCTS COMPOSITION

1 ACTIVE TABLETS

Each uncoated tablet contains : Acetyl Salicyclic acid BP 600 mg, Paracetamol BP 300 mg, Caffeine anhydrous BP 50 mg

2 BALMIXAGRIP PLUS TABLETS

Each uncoated tablet contains : Paracetamol BP 500 mg, Phenylephrine Hcl BP 5 mg Chlorpheniramine Maleate BP 2 mg, Caffeine anhydrous BP 30 mg

3 ENDCOLD TABLETS

Each uncoated tablet contains : Paracetamol BP 500 mg, Phenylpropanolamine Hcl BP 12.5 mg, Chlorpheniramine Maleate BP 2 mg, Caffeine anhydrous BP 30 mg

4 ENDCOLD KID SUSPENSION

Each 5 ml contains : Paracetamol BP 125 mg, Phenylpropanolamine Hcl BP 10 mg, Chlorpheniramine Maleate BP 2 mg,

5 ENDCOLD KID PLUS SUSPENSION

Each 5 ml contains : Paracetamol BP 125 mg, Phenylephrine Hcl BP 2.5 mg,

Chlorpheniramine Maleate BP 2 mg,

6 KOFEND-D SYRUP

Each 5ml contains : Dextromethorphan Hydrobromide BP 10 mg, Chlorpheniramine Maleate BP 2mg, Metholated Syrup Base q.s Terbutaline Sulphate BP 1.25 mg,

7 BRONKEX EXPECTORANT Each 5 ml contains : Bromhexine Hcl BP 4 mg, Guaphensien BP 50 mg

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STEROIDS

SL. NO

PRODUCTS COMPOSITION

1 BALESTON TABLETS Each uncoated tablet contains : Betamethasone BP 0.5 mg

2 BALSOLONE TABLETS Each uncoated tablet contains : Prednisolone BP 5 mg / 10 mg

SEDATIVE / TRANQUILIZERS / HYPNOTICS

SL.

NO PRODUCTS COMPOSITION

1 LORIVAN TABLETS Each uncoated tablet contains : Lorazepam BP 1 mg / 2 mg

2 TENSYL TABLETS Each uncoated tablet contains : Alprazolam BP 0.25 mg / 0.5 mg

ERECTILE DYSFUNCTION

SL. NO

PRODUCTS COMPOSITION

1 SEREGRA TABLETS Each tablet contains : Sildenafil Citrate equivalent to Sildenafil 50 mg / 100 mg

2 MIALIS TABLETS Each film coated Tablet contains: Tadalafil 10 mg / 20 mg

NEW PRODUCTS UNDER DEVELOPMENT

SL. NO

PRODUCTS COMPOSITION

1 BEZY MOUTHWASH Benzydamine Hcl BP 0.15% w/v (Non-alcholic base)

2 TOLTERODINE TARTRATE TABLETS

Each tablet contains : Tolterodine Tartrate BP 1 mg / 2 mg

3 GLUCOSAMINE & CHONDROITIN TABLETS

Each tablet contains : Glucosamine USP 500 mg Chondroitin USP 400 mg

4 VITAMIN B COMPLEX

TABLETS

Each Uncoated Tablet Contains: Thiamine hydrochloride BP (Vitamin B1) 5mg Riboflavin BP (Vitamin B2) 5mg

Pryidoxine Hydrochloride BP(Vitamin B6) 2mg Nicotinaminde BP (Niacinamide) 50mg Calcium Pantothenate BP 5mg

5 FERROUS SULFATE & FOLIC ACID TABLETS

Each film coated Tablet contains: Dried ferrous sulfate BP 200mg equivalent to elemental Iron 60mg Folic Acid BP 0.4mg

6

ESSENTIALS

PHOSPHOLIPIDS WITH MULTI VITAMINS

Each Capsule Contains: Essential Phospholipids 300mg, Thiamine Nitrate BP 6mg,

Riboflavin BP 6mg, Pyridoxine Hydrochloride BP 6mg, Cynanocobalamin BP 6mcg, Nicotinamide BP 30mg, Tocopheryl Acetate BP 6mg

7 BETHANECHOL CHLORIDE TABLETS

Each Uncoated tablet Contains: Bethanechol Chloride USP: 50mg/25mg/10mg/5mg

8 LUMEFANTRINE & ARTEMETHER TABLETS

Each Uncoated Tablet Contains: Lumefantrine USP / Artemether USP -

120mg/20mg ; 240mg/40mg ; 480mg/80mg

Page 16: Bal Pharma Ltd. - Dossier & Finished Dosage Formulation ... · 18 MONOGESIC GEL Each gram contains : Nimesulide BP 10 mg 19 REGAFLAM TABLETS Each uncoated tablet contains : Ibuprofen