NPPA Fixes Retail Prices of 70 Formulations, Details

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), the Ministry of Chemicals and Fertilizers, the Government of India, has fixed retail prices of 70 formulations under the Drugs (Prices Control) Order, 2013.

This came in line with the decision of the 125th Authority meeting dated 25.07.2024 where the authority discussed new drug applications for price fixations under para 5 and para 15 of DPCO 2013.

The Authority deliberated on 70 (seventy) cases of retail price fixation of new drugs falling under the purview of Para 2(1)(u) of DPCO, 2013.

The Authority approved the retail prices of 58(fifty-eight) new drugs under Para 5 and 15 of the DPCO 2013, as detailed in Table 1. Furthermore, the authority with respect to 12 (twelve) cases, noticed that the companies have launched the formulations without obtaining price approval from NPPA. The Authority deliberated upon the worked-out price, claimed price, and the launched price and approved the lowest of the three prices as the retail price of the new drugs as given in Table 2.

The list of formulations includes Akum Pharmaceutical/Dr. Reddy Laboratories' paracetamol infusion, Akums Drugs and Pharmaceutical's / Ipca Laboratories' Metoprolol Succinate (Extended Release), Amlodipine and Telmisartan Tablet, Alkem Health Science (A unit of Alkem Laboratories Ltd.) / Alkem Laboratories' Paracetamol Tablet, GMH Organics/ Orchid Pharma's Ceftazidime 2gm/ Avibactam 0.5gm powder for concentrate solution for infusion, Akums Drugs and Pharmaceuticals/Mankind Pharma's Metoprolol Succinate (Extended Release), Amlodipine and Telmisartan Tablet others.

The notice stated that in exercise of the powers conferred by paragraphs 5, 11, and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May 2013 and S. O. 5249(E) dated 11th November 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (NPPA), has fixed, the price as specified in column (6) of the Table herein below as the retail price, exclusive of Goods and Services Tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer and marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof;

Table 1: Retail Price Fixation of New Drugs

Sl. No.

Medicines

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(3)

(4)

(5)

(6)

(7)

1

Paracetamol Infusion IP

Each 100ml contains: Paracetamol IP 1000mg water for Injection

1 ml

M/s Akums Drugs & Pharmaceuticals Ltd. / Dr. Reddy's Laboratories Limited

3.58

2

Paracetamol, Phenylephrine

Each uncoated tablets contains:

1 Tablet

M/s East African (India) Overseas / M/s

4.83

Sl. No.

Medicines

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(3)

(4)

(5)

(6)

(7)

Hydrochloride & Chlorpheniramine maleate Tablets

Paracetamol IP 500mg Phenylephrine Hydrochloride IP 10mg

Chlorpheniramine maleate IP 2mg

Softdeal Pharmaceutical Private Limited

3

Metoprolol Succinate (Extended Release), Amlodipine & Telmisartan Tablet

Each film coated bilayered tablet contains:

Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate 50mg (As Extended release form)

Amlodipine Besilate IP eq. to Amlodipine 5mg

Telmisartan IP 40mg

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Ipca Laboratories Limited

14.50

4

Paracetamol Tablet IP 1000mg

Each uncoated tablet contains:

Paracetamol IP 1000mg

1 Tablet

M/s Alkem Health Science (A unit of Alkem Laboratories Ltd.) / M/s Alkem

Laboratories Limited

4.08

5

Ceftazidime 2gm/ Avibactam 0.5gm powder for concentrate solution for infusion

Each vial contains:

Sterile Ceftazidime Pentahydrate IP eq. to Anhydrous Ceftazidime 2gm

(added Sodium carbonate as buffering agent)

Sterile Avibactam Sodium eq. to Avibactam 0.5gm

1 Vial

M/s GMH Organics

/M/s Orchid Pharma Limited

1572.59

6

Metoprolol Succinate (Extended Release), Amlodipine & Telmisartan Tablet

Each film coated bilayered tablet contains:

Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate 50mg (As Extended release form)

Amlodipine Besilate IP eq. to Amlodipine 5mg

Telmisartan IP 40mg

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Mankind Pharma Ltd.

14.50

7

Atorvastatin and Ezetimibe Tablets

Each film coated tablet contains:

Atorvastatin Calcium IP eq. to Atorvastatin 20mg

Ezetimibe IP 10mg

1 Tablet

M/s Pure & Cure Healthcare Pvt. Ltd. / M/s Ipca Laboratories Limited

24.74

8

Omeprazole Injection

Each vial contains:

Omeprazole IP (Sterile) 40mg

1 Vial

M/s Skymap Pharmaceuticals Pvt. Ltd. / M/s German Remedies Pharmaceuticals Private

Ltd.

40.17

9

Atorvastatin and Ezetimibe Tablets

Each film coated tablet contains:

Atorvastatin Calcium IP eq. to Atorvastatin 40mg

Ezetimibe IP 10mg

1 Tablet

M/s Pure& Cure Healthcare Pvt. Ltd. / M/s Ipca Laboratories Limited

33.63

10

Combikit of Clarithromycin Tablets IP, Esomeprazole Tablets IP &

Amoxicillin Tablets

Composition:

Each Strip contains:

A. Clarithromycin Tablets IP 2 Tablets

Each film coated tablet contains: Clarithromycin IP 500mg

1 kit

M/s Malik Lifesciences Pvt. Ltd. / M/s Natco Pharma Limited

205.48

Sl. No.

Medicines

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(3)

(4)

(5)

(6)

(7)

USP

B. Esomeprazole Tablets IP 2 Tablets

Each Enteric coated tablet contains:

Esomeprazole Magnesium Trihydrate IP eq. to Esomeprazole 40mg

C. Amoxicillin Tablets USP 2 Tablets

Each Film coated tablet contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 1000mg

11

Rosuvastatin and Clopidogrel Tablets

Each film coated tablet contains:

Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg

1 Tablet

M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Torrent Pharmaceuticals Ltd.

19.00

12

Rosuvastatin and Clopidogrel Tablets

Each film coated tablet contains:

Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg

1 Tablet

M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Torrent Pharmaceuticals Ltd.

15.60

13

Ceftriaxone and Sulbactam for Injection 1.5 gm

Each vial contains: Ceftriaxone Sodium IP (Sterile) eq. to Anhydrous Ceftriaxone 1000mg

Sulbactam Sodium IP (Sterile) eq. to Sulbactam 500mg

1 Vial

M/s Aqua Vitoe Laboratories /M/s Orchid Pharma Limited

153.06

14

Meropenem and Sulbactam for Injection 1.5 gm

Each vial contains:

Sterile Meropenem Trihydrate IP eq. to Anhydrous Meropenem 1000mg

Sterile Sodium Carbonate IP Eq. to Sodium 90.2mg (as buffer) Sterile Sulbactam Sodium IP eq. to Sulbactam 500mg

1 Vial

M/s GMH Organics

/M/s Orchid Pharma Limited

1620.01

15

Fexofenadine Hydrochloride and Montelukast tablets

Each film coated bilayer tablet contains:

Fexofenadine Hydrochloride IP 180mg

Montelukast Sodium IP eq. to Montelukast 10mg

1 Tablet

M/s Exemed Pharmaceuticals / M/s Sun Pharmaceutical Industries Limited

17.90

16

Metoprolol Succinate Extended Release, Amlodipine & Telmisartan Tablet

Each film coated bilayered tablet contains:

Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate 50mg (As Extended release)

Amlodipine Besilate IP eq. to Amlodipine 5mg

Telmisartan IP 40mg

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Intas Pharmaceuticals Limited

14.50

17

Metoprolol Succinate Extended Release, Amlodipine &

Telmisartan Tablet

Each film coated bilayered tablet contains:

Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate 50mg (As Extended

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Glenmark Pharmaceuticals Ltd.

14.50

Sl. No.

Medicines

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(3)

(4)

(5)

(6)

(7)

release)

Amlodipine Besilate IP eq. to Amlodipine 5mg

Telmisartan IP 40mg

18

Atorvastatin and Clopidogrel Capsule

Each hard gelatine capsule contains:

Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As pellets form),

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets form)

1 Capsule

M/s Aeon Formulations Pvt. Ltd. / M/s Ipca Laboratories Limited

14.48

19

Atorvastatin and Clopidogrel Capsule

Each hard gelatine capsule contains:

Atorvastatin Calcium IP eq. to Atorvastatin 20mg (As pellets form),

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets form)

1 Capsule

M/s Aeon Formulations Pvt. Ltd. / M/s Ipca Laboratories Limited

19.05

20

Calcium Citrate Malate and Vitamin D3 Tablets

Each film coated Tablet Contains:

Calcium Citrate Malate IP eq. to elemental Calcium 250mg Vitamin D3 IP 1000 IU

1 Tablet

M/s Alkem Health Science (A unit of Alkem Laboratories Ltd.)/ M/s Alkem

Laboratories Limited

11.02

21

Telmisartan and Cilnidipine tablets

Each film coated tablet contains:

Telmisartan IP 40mg Cilnidipine IP 20mg

1 Tablet

M/s Macleods Pharmaceuticals Limited

14.28

22

Cefixime and Ofloxacin Tablets

Each film coated Tablet contains:

Cefixime IP eq. to Anhydrous Cefixime 200mg

Ofloxacin IP 200mg

1 Tablet

M/s Skymap Pharmaceuticals Pvt. Ltd. / M/s Eris Healthcare Pvt. Ltd.

14.13

23

Adapalene and Benzoyl Peroxide gel

Each gram of gel contains:

Adapalene 0.1% w/w

Hydrous Benzoyl Peroxide eq. to Benzoyl Peroxide 2.5% w/w (as microsphere)

1 Gram

M/s Swiss Garnier Life Sciences / M/s Mankind Pharma Ltd.

21.98

24

Cyclosporine Eye Drops

Composition: Cyclosporine IP 0.05% w/v Sterile Aqueous Vehicle

1 ml

M/s Appasamy Ocular Devices (P) Ltd. / M/s Mankind Pharma Ltd.

95.06

25

Bisoprolol Fumarate and Telmisartan Tablets

Each film coated tablet contains:

Bisoprolol Fumarate IP 2.5 mg Telmisartan IP 40 mg

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Ipca Laboratories

Ltd.

9.65

26

Bisoprolol Fumarate and Telmisartan Tablets

Each film coated tablet contains:

Bisoprolol Fumarate IP 5 mg Telmisartan IP 40 mg

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Ipca Laboratories Ltd.

11.21

27

Cefpodoxime & Potassium Clavulanate Tablets

Each film coated tablet contains:

Cefpodoxime Proxetil IP eq. to Cefpodoxime 200mg Potassium Clavulanate Diluted

IP eq. to Clavulanic Acid 125mg

1 Tablet

M/s Malik Lifesciences Pvt. Ltd. / M/s Blue Cross Laboratories Pvt. Ltd.

29.21

28

Linagliptin & Metformin

Each film coated bilayered tablet contains:

1 Tablet

M/s Synokem Pharmaceuticals Ltd. /

8.38

Sl. No.

Medicines

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(3)

(4)

(5)

(6)

(7)

Hydrochloride (ER) Tablets

Linagliptin 2.5mg Metformin Hydrochloride IP 500mg (as extended release)

M/s Cipla Limited

29

Linagliptin and Metformin Hydrochloride Tablets

Each film coated bilayered tablet contains:

Linagliptin 5mg

Metformin Hydrochloride IP 500mg (As Extended release form)

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s La Renon Healthcare Pvt. Ltd.

12.47

30

Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablet

Each film coated tablet contains:

Dolutegravir Sodium eq. to 50mg of Dolutegravir

Tenofovir Alafenamide 25mg (eq. to 28mg of Tenofovir Alafenamide fumarate), Emtricitabine 200mg

1 Tablet

M/s APL Healthcare Ltd. / M/s Aurobindo Pharma Limited

121.21

31

Bisoprolol and Telmisartan Tablets

Each film coated tablet contains:

Bisoprolol Fumarate IP 2.5 mg Telmisartan IP 40 mg

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Aristo Pharmaceuticals Pvt.

Ltd.

9.65

32

Bisoprolol and Telmisartan Tablets

Each film coated tablet contains:

Bisoprolol Fumarate IP 5 mg Telmisartan IP 40 mg

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Aristo

Pharmaceuticals Pvt. Ltd.

11.21

33

Sitagliptin and Glimepiride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg

Glimepiride IP 2 mg

1 Tablet

M/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited

15.27

34

Sitagliptin and Glimepiride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg

Glimepiride IP 1 mg

1 Tablet

M/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited

13.59

35

Dapagliflozin, Metformin Hydrochloride (Extended Release) and Glimepiride Tablets

Each film coated bilayered tablet contains:

Dapagliflozin Propanediol USP eq. to Dapagliflozin 10mg Metformin Hydrochloride IP

500mg (As Extended release) Glimepiride IP 1 mg

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Intas Pharmaceuticals Ltd.

13.63

36

Dapagliflozin, Metformin Hydrochloride (Extended Release) and Glimepiride Tablets

Each film coated bilayered tablet contains:

Dapagliflozin Propanediol USP eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 500mg (As Extended release) Glimepiride IP 2 mg

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Intas Pharmaceuticals Ltd.

15.31

37

Sitagliptin, Metformin

Hydrochloride and

Each film coated tablet contains:

Sitagliptin Phosphate

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s

Alembic

15.22

Sl. No.

Medicines

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(3)

(4)

(5)

(6)

(7)

Glimepiride Tablets

Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 1000mg

Glimepiride IP 2 mg

Pharmaceuticals Limited

38

Sitagliptin, Metformin Hydrochloride and Glimepiride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 1000mg

Glimepiride IP 1 mg

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Alembic Pharmaceuticals Limited

13.54

39

Linagliptin, Dapagliflozin & Metformin Hydrochloride (SR) Tablets

Each film coated bilayer tablet contains:

Linagliptin 5mg Dapagliflozin Propanediol Monohydrate USP eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 500mg (as sustained release

form)

1 Tablet

M/s Theon Pharmaceuticals Ltd. / M/s La Renon Healthcare Pvt. Ltd.

19.43

40

Linagliptin, Dapagliflozin & Metformin Hydrochloride (SR) Tablets

Each film coated bilayer tablet contains:

Linagliptin 5mg Dapagliflozin Propanediol Monohydrate USP eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 1000mg (as sustained release

form)

1 Tablet

M/s Theon Pharmaceuticals Ltd. / M/s La Renon Healthcare Pvt. Ltd.

20.73

41

Dapagliflozin, Metformin Hydrochloride (Extended Release) and Glimepiride Tablets

Each film coated bilayered tablet contains:

Dapagliflozin Propanediol USP eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 1000mg (As Extended release)

Glimepiride IP 2 mg

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Aprica Healthcare Limited

16.69

42

Dapagliflozin, Metformin Hydrochloride (Extended Release) and Glimepiride Tablets

Each film coated bilayered tablet contains:

Dapagliflozin Propanediol USP eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 500mg (As Extended release) Glimepiride IP 1 mg

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Aprica Healthcare Limited

13.68

43

Dapagliflozin, Metformin Hydrochloride (Extended Release) and Glimepiride Tablets

Each film coated bilayered tablet contains:

Dapagliflozin Propanediol USP eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 500mg (As Extended release) Glimepiride IP 2 mg

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Aprica Healthcare Limited

15.36

44

Dapagliflozin, Metformin Hydrochloride (Extended Release) and Glimepiride

Tablets

Each film coated bilayered tablet contains:

Dapagliflozin Propanediol USP eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 1000mg (As Extended release)

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Aprica Healthcare Limited

15.01

Sl. No.

Medicines

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(3)

(4)

(5)

(6)

(7)

Glimepiride IP 1 mg

45

Sitagliptin Phosphate, Metformin Hydrochloride and Glimepiride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 500mg

Glimepiride IP 1 mg

1 Tablet

M/s Sun Pharma Laboratories Limited

12.19

46

Sitagliptin Phosphate, Metformin Hydrochloride and Glimepiride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 500mg

Glimepiride IP 2 mg

1 Tablet

M/s Sun Pharma Laboratories Limited

13.87

47

Paracetamol and Caffeine Tablets

Each uncoated tablet contains:

Paracetamol IP 500mg Caffeine IP (Anhydrous) 50mg

1 Tablet

M/s Juggat Pharma (Pharma Division of Jagdale Industries Pvt. Ltd.)

2.38

48

Teneligliptin, Dapagliflozin & Metformin Hydrochloride (Sustained Release) Tablets

Each film coated bilayer tablet contains:

Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin 20mg

Dapagliflozin Propanediol USP eq. to Dapagliflozin 10mg

Metformin Hydrochloride IP 1000mg (As Sustained Release)

1 Tablet

M/s Synokem Pharmaceuticals Ltd. / M/s Blue Cross Laboratories Pvt. Ltd.

14.21

49

Ceftazidime and Avibactam powder for concentrate for solution for infusion

Each vial contains:

Sterile Ceftazidime Pentahydrate IP eq. to Anhydrous Ceftazidime 2.0gm

(added Sodium carbonate as buffering agent)

Sterile Avibactam Sodium eq. to Avibactam 0.5gm

I Vial

M/s GMH Organics

/M/s Zyphars Pharmaceutics Pvt. Ltd.

1572.59

50

Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet

Each film coated Bilayered Tablet Contain:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg

Pioglitazone Hydrochloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP

500mg (Sustained Release Form)

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd.

14.00

51

Glimepiride, Voglibose & Metformin Hydrochloride (Extended-release)

tablet

Each uncoated Bilayered tablet contains:

Glimepiride IP 2mg Voglibose IP 0.2mg Metformin Hydrochloride IP

1000mg (As Extended Release)

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd.

14.08

52

Glimepiride, Voglibose & Metformin Hydrochloride

(Extended-release)

Each uncoated Bilayered tablet contains:

Glimepiride IP 1mg Voglibose IP 0.2mg Metformin Hydrochloride IP

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd.

11.51

Sl. No.

Medicines

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(3)

(4)

(5)

(6)

(7)

tablet

1000mg (As Extended Release)

53

Telmisartan, Amlodipine & Hydrochlorothiazide Tablet

Each uncoated bilayered tablet contains:

Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Hydrochlorothiazide IP 12.50 mg

1 Tablet

M/s Uni Medicolabs / M/s Torrent Pharmaceuticals Ltd.

10.23

54

Telmisartan, Amlodipine & Hydrochlorothiazide Tablet

Each uncoated bilayered tablet contains:

Telmisartan IP 80mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Hydrochlorothiazide IP 12.50 mg

1 Tablet

M/s Uni Medicolabs / M/s Torrent Pharmaceuticals Ltd.

16.48

55

Cholecalciferol Vitamin D3 Oral solution

Each 5ml contains:

Cholecalciferol IP 60000 IU

1 ml

M/s Ravenbhel Healthcare Pvt. Ltd. /

M/s Torrent Pharmaceuticals Ltd.

13.92

56

Aspirin and Clopidogrel capsules

Each hard gelatin capsule contains:

Clopidogrel Bisulphate eq. to Clopidogrel 75mg

Aspirin IP (as enteric coated tablets) 75mg

1 Capsule

M/s Windlas Biotech Limited / M/s Modi- Mundipharma Pvt. Ltd.

4.95

57

Bisoprolol Fumarate and Amlodipine Tablets

Each film coated tablet contains:

Bisoprolol Fumarate IP 2.5 mg Amlodipine Besylate IP eq. to Amlodipine 5mg

1 Tablet

M/s Swiss Garnier Biotech Private Limited

/ M/s Ipca Laboratories Limited

6.23

58

Bisoprolol Fumarate and Amlodipine Tablets

Each film coated tablet contains:

Bisoprolol Fumarate IP 5 mg Amlodipine Besylate IP eq. to Amlodipine 5mg

1 Tablet

M/s Swiss Garnier Biotech Private Limited

/ M/s Ipca Laboratories Limited

8.97

Table 2: Retail Price Fixation of New Drugs Launched Without Price Approval

S. No.

Medicines

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(3)

(4)

(5)

(6)

(7)

1.

Telmisartan and Chlorthalidone Tablet

Each uncoated bilayered tablet contains: Telmisartan IP 40mg

Chlorthalidone IP 6.25mg

1 Tablet

M/s Innova Captab Ltd./ M/s Corona Remedies Pvt. Ltd.

5.80

2.

Dapagliflozin, Vildagliptin (SR) and Metformin Hydrochloride (SR) Tablets

Each uncoated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Vildagliptin IP 100mg (As Sustained release from) Metformin Hydrochloride

IP 500mg (as Sustained Release from)

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Macleods Pharmaceuticals Ltd.

13.17

3.

Dapagliflozin, Sitagliptin and Metformin Hydrochloride (Extended release) Tablets

Each film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride

IP 500mg (as extended release)

1 Tablet

M/s Synokem Pharmaceuticals Limited / M/s Unison Pharmaceuticals Pvt.

Ltd.

10.27

4.

Dapagliflozin, Sitagliptin and Metformin Hydrochloride (Extended release) Tablets

Each film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to

Sitagliptin 100mg

1 Tablet

M/s Synokem Pharmaceuticals Limited / M/s Unison Pharmaceuticals Pvt.

Ltd.

11.16

Metformin Hydrochloride IP 1000mg (as extended release)

5.

Teneligliptin, Dapagliflozin & Metformin Hydrochloride (Sustained Release) Tablets

Each film coated bilayer tablet contains: Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin 20mg Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 500mg (As Sustained

Release)

1 Tablet

M/s Synokem Pharmaceuticals Ltd. / M/s Glenmark Pharmaceuticals Limited

12.15

6.

Teneligliptin, Dapagliflozin & Metformin Hydrochloride (Sustained Release) Tablets

Each film coated bilayer tablet contains: Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin 20mg Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 1000mg (As Sustained

Release)

1 Tablet

M/s Synokem Pharmaceuticals Ltd. / M/s Glenmark Pharmaceuticals Limited

13.39

7

Sitagliptin and Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg Metformin Hydrochloride

IP 1000mg

1 Tablet

M/s Corona Remedies Pvt. Ltd.

12.41

8

Sitagliptin and Metformin Hydrochloride (ER) Tablets

Each film coated bilayered tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (As Extende

Release form)

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Corona Remedies Pvt. Ltd.

14.20

9

Sitagliptin and Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg Metformin Hydrochloride IP 500mg

1 Tablet

M/s Corona Remedies Pvt. Ltd.

6.49

10

Sitagliptin and Metformin Hydrochloride (ER) Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 100mg Metformin Hydrochloride

(as Extended Release) IP 500mg

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Corona Remedies Pvt. Ltd.

13.30

11

Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets

Each film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg

Sitagliptin Phosphate IP eq. to Sitagliptin 100mg

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Macleods Pharmaceuticals Ltd.

15.89

Metformin Hydrochloride (as Extended Release) IP 500mg

12

Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets

Each film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate IP eq. to Sitagliptin 100mg Metformin Hydrochloride (as Extended Release) IP

1000mg

1 Tablet

M/s Mascot Health Series Pvt. Ltd. / M/s Macleods Pharmaceuticals Ltd.

17.50

The notice further added:
  • The manufacturer of above-mentioned formulations i.e., “new drug” under paragraph 2(1)(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove.
  • The manufacturer may add Goods and Services Tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table.
  • The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.
  • As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.
  • The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies.
  • In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.
  • Consequent to the fixation of retail price of such formulation as specified in column (2) of the above table with the strength and name of Manufacturer & Marketing Companies specified in the corresponding entries in Column (3) & (5) thereof, the price order(s) fixing the retail price of the formulation with specified strength for that Manufacturer & Marketing Companies as specified in corresponding entries in Column (2),(3) and (5) thereof, if any, issued before this notification, stand(s) superseded.

Also Read:MSN Laboratories gets CDSCO Panel nod to conduct Bioequivalence Study of Abiraterone Tablets1000mg



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