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A fixed dose combination (FDC) is a formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Fixed dose combination drug products may improve patient compliance by reducing the no. of pills to a patient.Fixed dose combination drug products are developed to target both a single disease and multiple diseases.

Since FDCs are reviewed by the regulatory bodies, the active ingredients used in the FDC are unlikely to exhibit adverse drug interactions with each other. However, FDCs may interact with other drugs that a patient is taking.

Fixed dose combination drug products may be developed by a pharmaceutical company as a way to extend the marketability of a drug product.

These FDCs need mandatory approval and license for manufacture. The permission is granted by Drug Controller General of India (DCGI) and manufacturing license is issued by the State Drug Controller on the basis of permission granted by DCGI.

Presently, 294 FDCs are pending for approval by the DCGI after the licenses were issued from State Drug Controller. Out of the 294 FDCs, 78 FDCs are liable to get approval by the DCGI under certain conditions. The list of those 78 FDCs is as given below:

S.No.	Name of FDC	Category	Remarks
1.	Ibuprofen + Colchicine	Orthopedics
2.	Aloe extract + Allantocin + Alfa tocoferal acetate + D-panthemol + Vit A	Dermatologicals	Should be Topical
3.	Allantoin + Vit-E + Cammelina Sinensis	Dermatologicals	Should be Topical
4.	Aloe extract + Vit-E + Dimethicone + Glycerine	Dermatologicals	Should be Topical
5.	Aloe vera + jojoba oil + Vit-E	Dermatologicals	Should be Topical
6.	Aloe vera + Orange oil	Dermatologicals	Should be Topical
7.	Aloe vera + Vit-E acetate	Dermatologicals	Should be Topical
8.	Aloe + tocopherol	Dermatologicals	Should be Topical
9.	Aloe vera + Glycerine + PFG 100 stearate + Vit-E	Dermatologicals	Should be Topical
10.	Aloe vera + Jojoba Oil + Wheat germ oil + Tea tree oil	Dermatologicals	Should be Topical
11.	Aloe vera + Vit-E + Herbal	Dermatologicals	Should be Topical
12.	Chlorzoxazone + Nimesulide	Orthopaedics
13.	Chlorzoxazone + Paracetamol	Orthopaedics
14.	Diclofenac + Tizanidine	Orthopaedics
15.	Drotaverine hydrochloride + Mefenamic acid	Gastrointestinal
16.	Drotaverine + Mefenamic acid	Gastrointestinal
17.	Drotaverine + Nimesulide	Gastrointestinal
18.	Ibuprofen + Dextropropoxyphene	Orthopaedics
19.	Ibuprofen + Tizanidine	Orthopaedics
20.	Mecobalaminalphalipoic Acid + Folic acid + Vit B6 + Choline	Nutritionals	Doses of Vitamins should be as per Schedule V
21.	Mecobalamine + Alpha lipoic acid	Nutritionals	Doses of Vitamins should be as per Schedule V
22.	Mecobalamine + Alpha lipoic acid + Folic acid	Nutritionals	Doses of Vitamins should be as per Schedule V
23.	Mecobalamine + Alpha lipoic acid + Vit B1 + Folic acid.	Nutritionals	Doses of Vitamins should be as per Schedule V
24.	Mecobalamine + Biotin	Nutritionals	Doses of Vitamins should be as per Schedule V
25.	Mecobalamine + Calcium panothenate	Nutritionals	Doses of Vitamins should be as per Schedule V
26.	Mecobalamine + Carotinoid + Alpha lipoic acid + Chromim + Vit B1 + Vit B Complex	Nutritionals	Doses of Vitamins should be as per Schedule V
27.	Mecobalamine + Folic acid	Nutritionals	Doses of Vitamins should be as per Schedule V
28.	Mecobalamine + Methenamine mandelate	Nutritionals	Doses of Vitamins should be as per Schedule V
29.	Mecobalamine + Vit-A + Vit-E + Vit-C + Vit-B1 + Vit-B6 + Vit-D3 + Selenium	Nutritionals	Doses of Vitamins should be as per Schedule V
30.	Mecobalamine +Vitamins + Minerals	Nutritionals	Doses of Vitamins should be as per Schedule V
31.	Mecobalamine + Vit-B1 + Vit-B2 + Vit-B6 + Folic acid	Nutritionals	Doses of Vitamins should be as per Schedule V
32.	Mecobalamine + Vit-B1 + Vit-B6 + Folic acid + Alpha lipoic	Nutritionals	Doses of Vitamins should be as per Schedule V
33.	Mecobalamine + Vit-B1 + Vit-B6 + Nicotinamide + D-Panthenol	Nutritionals	Doses of Vitamins should be as per Schedule V
34.	Mecobalamine + Vit B6 + Folic acid	Nutritionals	Doses of Vitamins should be as per Schedule V
35.	Acetylcysteine + Selenomethionone + choline Bitartrate + Pyridoxine + Folic Acid+Vitamin E + Cyanocobalmin + Chromium Nicotinate + Manganese Sulfate + Zinc Sulfate	Nutritionals	Doses of Vitamins should be as per Schedule V
36.	Acriflavine + Gentain violet + Brilliant green	Dermatologicals	Should be topical
37.	Alendronate sodium + Calcium carbonate + Vit-D3	Orthopaedics
38.	Allantoin + Triclosan + Vit-E + Zinc Oxide	Dermatologicals	Should be topical
39.	Drotaverine + Paracetamol	GI
40.	Ibuprofen + Paracetamol + caffeine	Cough & Cold
41.	Ibuprofen + Pseudoephedrine + Chlorpheniramine	Cough & Cold
42.	Metoclopramide hydrochloride + Paracetamol	GI
43.	Acetyl salicylic acid + Ethoheptazine	Analgesics
44.	Norfloxacin + Ornidazole	GI
45.	Ofloxacin + Tinidazole	GI
46.	Aceclofenac + Tramadol	Orthopaedics
47.	5-bromosalicyl-4-chloranilide + salicylic acid	Dermatologicals	Should be topical
48.	Ofloxacin + Prednisolone	Opthalmic	Should be opthalmic solution
49.	Lansoprazole + Amoxycillin + Clarithromycin	GI	Should be combipack
50.	Lansoprazole + Amoxycillin + Tinidazole	GI	Should be combipack
51.	Lansoprazole + Tinidazole + Clarithromycin	GI	Should be combipack
52.	Ornidazole + Flucanazole + Azithromycin	Antimicrobial	Should be combipack
53.	Clinamycin + Clotrimazole + Metronidazole	Dematologicals	Should be topical
54.	Mupirocin + Metronidazole	Dematologicals	Should be topical
55.	Benfotimine + Pyridoxine + Mecobalamine + Inositol + Alphalipoic acid	Nutritionals	Doses of Vitamins should be as per schedule V
56.	Amoxycillin + Clavulanic acid + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
57.	Amoxycillin + Clavulanic acid + Lactobacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
58.	Amoxycillin + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
59.	Amoxycillin + Lactobacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
60.	Amoxycillin + Lactobacillus acidophilus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
61.	Amoxycillin + Lactobacillus acidophilus + Clavulanic acid	Antimicrobial	Dose of lactobacillus should be 5 billion per day
62.	Ampicillin + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
63.	Cefadroxyl + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
64.	Cefdinir + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
65.	Cefixime + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
66.	Cefixime + Lactobacillus acidophilus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
67.	Cefixime + Lactobacillus acvidophilus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
68.	Cefpodoximeprozetil + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
69.	Cefpodoxime + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
70.	Cefpodoxime + Lactobacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
71.	Cefprozil + Lactobacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
72.	Doxycycline + Lactobacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
73.	Lincomycin + Lactobacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
74.	AmoxicillinCloxacillin + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
75.	Amoxicillin + Cloxacillin + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
76.	Amoxicillin + Cloxacillin + Lacto acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
77.	Ampicillin + Cloxacillin + Lactic acid bacillus	Antimicrobial	Dose of lactobacillus should be 5 billion per day
78.	Cefixime + Lactobacillus + Clavulanic acid	Antimicrobial	Dose of lactobacillus should be 5 billion per day

We are a team of a Regulators & Pharmacists and our team is headed by Mr. B. N. Nagpal. He is in the industry as a veteran with more then 18 years of experience in regulatory affairs, business operations development and Sales & Marketing in pharmaceutical industry. We thrive on consistently achieving success in regulatory .