Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit

For iron, folic acid & omega-3-fatty acid deficiency 

Sphaeranthus Indicus Extract Tablets
700mg

For the management of psoriasis

Febuxostat 40mg Additional Strength

Same As approved

Dexamethasone Intravitreal Implant 0.7mg
(in solid polymer drug delivery system)

Buclizine Hcl 25mg Tablet (Additional
Indication)

For the Symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness

Pemetrexed Disodium 500mg/100mg
Powder for Injection (additional indication)

Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.  First line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel.

Levobetaxolol HCl Opthalmic Suspension 0.5%

For lowering of intraoccular pressure in patients with chronic open-angle glaucoma or occular hypertension.

Sarpogrelate Hydrochloride film coated
Tablets 100mg

For the improvement of ischemic symptoms including ulcer, associated with chronic arterial occlusion.

Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution

For hygenic and surgical hand disinfection

Aliskiren 150/160mg + Valsartan  300/320mg tablets

For the treatment of hypertension

Piroxicam 20mg tab& Paracetamol 500mg tab combikit 

For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes.

Soybean oil 60gm + Triglycerides
(medium chain) 50gm + olive oil  purified
fish oil 30gm + dl-alpha-tocopherol 163-
225mg + glycerol (anhydrous) 25gm +
Egg lecithin 12gm + sodium hydroxide (to
approx pH 8) + sodium pleate 0.3mg
emulsion for infusion in 100ml.

Raltegravir (as Potassium) film coated Tablets 400mg

In combination with other anti retroviral agents for  the treatment of human immunodeficiency virus (HIV-1) infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing retroviral therapy.

Deflazacort Tablet 18mg (Additional Strength)

Same as approved

Same as approved

Rivaroxaban film coated Tablets 10mg

For the prevention of venous thromboembolism in patients (VTE) in adult patients undergoing hip or knee replacement surgery.

Cinnarizine 20mg + Dimenhydrinate 40mg tablets 

For the treatment of vertigo

Lipid Based Amphotericin-B  Gel 0.1%

Indicated in the treatment of cutaneous and mucocutaneous mycotic infections caused by candida (Monilia) species.

Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength)

Same as approved

Milnacipran Hcl 12.5mg (Addl. Strength)

Same as approved

Ropinirole 6mg ER Tablets (Addl. Strength)

Same as approved

Coseal Surgical Sealent 2/4/8ml (Addl. Indication)

(1)  Enforcement of suture and staple lines in lung resection procedures.                                     (2)Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation.                 (3)Patients undergoing laparotomy or laproscopic abdomino-pelvic surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post surgical adhesion formation.

Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets 

For the treatment of adult patients with peripheral neuropathy

Ivabradine Hcl Tablets 5/7.5mg (Additional Indication)

For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm, indicated in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60bpm.

Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize)

Same as approved

Ketorolac Tromethamine Ophthalmic Solution 0.45%

Indicated for the treatment of pain and inflammation following cataract surgery.

Cytarabine Injection 100mg Additional Packsize (20ml)

In combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children.  It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.  Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia.

Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication)

For the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older.

Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm  + Magnesium chloride  hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion 

Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present

Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier.

As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement.

Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets

For the treatment of patients with acute painful musculoskeletal conditions

Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets

For the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections

Celecoxib Mouth Dissolving Tablet 50/100/200 mg

For the Treatment of Osteoarthritis and Rheumatoid Arthritis

Propofol 2% w/v Injection (additionalStrength)

Same as Approved

Spironolactone 25mg + Furosemide 20mg tablets

For treatment of resistant oedema associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis

Olopatadine5mg + Ambroxol30mg tablets 

For the management of cough in adult patients only 

Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules

For the treaetment of painful diabetic neuropathy in adults only

Calcium acetate 435mg + Magnesium carbonate 235mg tablets

For the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis

Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension.

For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc.

Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo

For the treatment in adults patients with dandruff/seborrheic dermatitis of the scalp

Faropenam Sodium Extended Release Tablet 225/300/450 mg

For the Treatment of respiratory tract infections, urinary tract infection, skin and skin structure infections and gynaecological infections

Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength)

For the treatment of hypertension only

Doxofylline MR Tablet 650 mg

For the treatment of Bronchial Asthma and COPD in Adults

Lidocaine7.5mg + Prilocaine2.5mg per acutation spray

For the treatment of adult male patients with premature ejaculation

Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg

For the treatment of the sign and symptoms of idiopathic parkinsons disease

Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets 

For the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication)

Miglitol 25 mg + Metformin 500mg tablets

Additional Strength

Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules 

For the prophylaxis of migraine

Citicholine 500mg + Piracetam 400mg Tablets 

For the treatment of acute stroke 

Diclofenac 50mg + Chlorzoxazone500mg Tablets

For the treatment of acute inflammation conditions associated with spasm in adults only

Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets

For the treatment of diabetic neuropathy in adults

Etoricoxib 1%+ Menthol 5% Spray 

For the topical treatment of acute musculoskeletal pain

Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules

For the treatment of patients suffering from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease (GERD)

Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules 

Additional higher strength

Lamotrigine Orodispersible Tablet 12.5 mg(additional strength)

Same as Approved

Trabectedin powder for Conc. solution for infusion (Additional Indication)

In combination with pegylated liposomal doxorubicin, it is indicated for the treatment of patients with relapsed platinum- sensitive ovarian cancer

Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets 

Additional higher strength

Diclofenac sodium SR Tablet 150 mg

For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondilytis,gout,painful post perative pain following dental surgery etc.

Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength)

Same as Approved 

Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel

Additional higher Strength

Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic Acid.........1000 mg
Laropiprant...........20mg

1. For the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDl-cholesterol) and in patients with primary hypercholesterolemia (heterozygous familial and non-familial).
2. In combination with HMG-CoA reductase inhibitors (statins), when cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet or other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy.

Pantoprazole Mouth Dissolving Tablet 20/40 mg

For the treatment of gastric ulcer, duodenal ulcer & gastroesophageal reflux disease (GERD).

Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets 

For the treatment of mixed infections with roundworms and tapeworms in dogs 

Difluprednate Opthalmic Emulsion 0.05% w/v

For the treatment of inflammation and pain 
associated with ocular surgery. 

Tolperisone Hcl SR 450mg Tablets

For the relief of painful muscle spasms of the skeletal muscualture.

S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets

For the treatment of patients with both essential hypertension and hypercholesterolemia

Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules

For secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate 

Lamotrigine 25mg Modified Release Tablet (Addl. Strength)

Same as Approved

Imatinib Mesylate 100/400mg Tablets (Addl. Indication)

Adjuvant treatment of adult patients following resection of gastro-intestinal stromal tumours (GIST)

Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength)

Same as Approved

Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication)

For the treatment of other dyslipidemias: (a) Fredrickson Types III and V.(b) Associated with diabetes.(C) Associated with xanthomata.

Ibuprofen 400mg + Chlorzoxazone 500mg Tablets

For the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only

Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets

For the treatment of bronchial asthma in adults

Dronedarone( as Hydrochloride) film coated tablet .... 400 mg. 

To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > 50mm or left ventricular ejection fraction [LVEF] < 40%), who are in sinus rhythm or who will be cardioverted.

Dosulepin Hcl Tablet 25mg/75mg (Additional Indication)

For the treatment of chronic pain.

Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.

To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
• Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). 
• Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.

Tofisopam uncoated tablet JP... 50/100mg

For the treatment of anxiety and depression.

Zotepine tablet ....25/50/100mg

For the treatment of schizophrenia

Armodafinil uncoated tablet ..50/150/250mg

To improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder (SWD) or narcolepsy.

Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules ….. ...150/300mcg

For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).

Ranolazine ER Tablets 750mg (Additional Strength)

Same as Approved

Tacrolimus Capsules 3mg (Additional Strength)

Same as approved

Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets

For the treatment of patients with typhoid fever and urinary tract infection in adults 

Liquid paraffin 6% + White soft paraffin 15%w/v Cream 

For symptomatic relief of dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis

Levosimendan Injection 2.5mg / ml

For the short term treatment of acutely decompensated chronic heart failure (ADHF) in situations where conventional therapy is not sufficient and in cases where ionotropic support is considered appropriate.

Thiocolchicosde SR Tablet 16mg

For the treatment of