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NPPA fixes retail prices of Linagliptin, Sitagliptin FDCs, Details

By - Ruchika Sharma
Published On 2022-05-11 12:30 GMT   |   Update On 2023-10-06 11:33 GMT
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New Delhi: Through a recent notice, National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of the fixed dose combinations (FDCs) involving 2 molecules Linagliptin and Sitagliptin and their combination with metformin. The two drugs in question are soon going to become off-patent in July and the price authority has been quick to respond to fix their combination with the other popular drug metformin that is already under price control.

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The  price fixation comes under the Drugs (Prices Control) Order, 2013 based on the decision of the 96th and 97th Authority meetings.

Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor used to manage hyperglycemia in patients with type 2 diabetes mellitus. Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes.

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes.

The retail prices of various companies have been fixed in the authority meeting by the NPPA, a few of them include: 

The retail price of Optimus Pharma and Natco Pharma's Linagliptin 2.5mg and Metformin Hydrochloride IP 500mg tablet has been fixed at Rs 8.04.

The retail price of MSN Laboratories and Emcure Pharma's Linagliptin 2.5mg and Metformin Hydrochloride IP 500mg tablet has been fixed at Rs 14.65.

The retail price of Alkem Healthsciences and Alkem Laboratories Limited's Sitagliptin Phosphate Monohydrate IP 64.25mg is eq. to Sitagliptin 50mg and Metformin Hydrochloride IP 1000mg has been fixed at Rs 20.02.

The retail price of Zydus Healthcare's Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg and Metformin Hydrochloride IP 500mg has been fixed at Rs 18.34.

Read also: Ahead of Sitagliptin going off-Patent, NPPA moves to fix retail price of its FDC

This comes after 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. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, 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 & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof;

Sl. No.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing

Company

Retail Price

(Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

1.

Linagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Linagliptin 2.5mg Metformin Hydrochloride IP 500mg

1

Tablet

M/s Optimus Pharma Pvt. Ltd. / M/s Natco Pharma Ltd.

8.04

2.

Linagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Linagliptin 2.5mg Metformin Hydrochloride IP 500mg

1

Tablet

M/s MSN Laboratories Private Limited / M/s Emcure Pharmaceuticals Limited

14.65

3.

Linagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Linagliptin 2.5mg Metformin Hydrochloride IP 500mg

1

Tablet

M/s MSN Laboratories Private Limited / M/s Eris Lifesciences Limited

14.65

4.

Linagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Linagliptin 2.5mg Metformin Hydrochloride IP

500mg

1

Tablet

M/s Micro Labs Limited

10.63

5.

Linagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Linagliptin 2.5mg Metformin Hydrochloride IP 1000mg

1

Tablet

M/s Optimus Pharma Pvt. Ltd. / M/s Natco Pharma Ltd.

8.37

6.

Linagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 1000mg

1

Tablet

M/s MSN Laboratories Private Limited / M/s Emcure Pharmaceuticals Limited

16.33

7.

Linagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Linagliptin 2.5mg Metformin Hydrochloride IP 1000mg

1

Tablet

M/s Micro labs Limited

11.52

8.

Linagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Linagliptin 2.5mg Metformin Hydrochloride IP 850mg

1

Tablet

M/s MSN Laboratories Private Limited / M/s Emcure Pharmaceuticals Limited

15.45

9.

Sitagliptin Phosphate + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP 64.25mg is eq. to Sitagliptin 50mg Metformin Hydrochloride IP 1000mg

1

Tablet

M/s Alkem Healthsciences (A Unit of Alkem Laboratories Ltd.) / M/s Alkem Laboratories Limited

20.02

10.

Sitagliptin Phosphate + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP 64.25mg is eq. to Sitagliptin 50mg Metformin Hydrochloride IP 500mg

1

Tablet

M/s Alkem Healthsciences (A Unit of Alkem Laboratories Ltd.) / M/s Alkem Laboratories

Limited

18.34

11.

Sitagliptin Phosphate + Metformin Hydrochloride(Extended release) Tablet

Each film coated bilayered tablet contains: Sitagliptin Phosphate eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (As an Extended

release form)

1

Tablet

M/s Alkem Healthsciences (A Unit of Alkem Laboratories Ltd.) / M/s Alkem Laboratories

Limited

20.17

12.

Sitagliptin Phosphate + Metformin Hydrochloride (Extended release) Tablet

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

1000mg (As an Extended release form)

1

Tablet

M/s Alkem Healthsciences (A Unit of Alkem Laboratories Ltd.) / M/s Alkem

Laboratories Limited

19.81

13.

Sitagliptin Phosphate + Metformin Hydrochloride Tablet

Each film coated tablet contains:

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

500mg

1

Tablet

M/s Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited

18.34

14.

Sitagliptin Phosphate + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 1000mg

1

Tablet

M/s Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited

20.02

15.

Sitagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 500mg

1

Tablet

M/s Zydus Healthcare Limited

18.34

16.

Sitagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg Metformin Hydrochloride IP 1000mg

1

Tablet

M/s Zydus Healthcare Limited

20.02

17.

Sitagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

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

1

Tablet

M/s Morepen Laboratories Limited

18.34

18.

Sitagliptin + Metformin Hydrochloride Tablet

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg Metformin Hydrochloride IP 1000mg

1

Tablet

M/s Morepen Laboratories Limited

20.02

19.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 500mg

1 Tablet

M/s Aristo Pharmaceuticals Pvt. Ltd.

18.34

20.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 1000mg

1 Tablet

M/s Aristo Pharmaceuticals Pvt. Ltd.

20.02

21.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP 64.25mg eq. to Sitagliptin 50mg Metformin Hydrochloride IP 500mg

1 Tablet

M/s Bajaj Healthcare Ltd. / M/s Lupin Limited

18.34

22.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP 64.25mg eq. to Sitagliptin 50mg Metformin Hydrochloride IP 1000mg

1 Tablet

M/s Bajaj Healthcare Ltd. / M/s Lupin Limited

20.02

23.

Sitagliptin & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP

500mg

1 Tablet

M/s Intas Pharmaceuticals Ltd.

18.34

24.

Sitagliptin & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 1000mg

1 Tablet

M/s Intas Pharmaceuticals Ltd.

20.00

25.

Sitagliptin & Metformin Hydrochloride

Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 500mg

1 Tablet

M/s Optimus Pharma Pvt. Ltd. / M/s Mankind

Pharma Ltd.

18.34

26.

Sitagliptin & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP

1000mg

1 Tablet

M/s Optimus Pharma Pvt. Ltd. / M/s Mankind Pharma Ltd.

20.02

27.

Sitagliptin & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 850mg

1 Tablet

M/s Optimus Pharma Pvt. Ltd. / M/s Mankind Pharma Ltd.

19.14

28.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP 64.25mg eq. to Sitagliptin 50mg Metformin Hydrochloride IP

500mg

1 Tablet

M/s Windlas Biotech Limited / Wockhardt Limited

8.92

29.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP 64.25mg eq. to Sitagliptin 50mg Metformin Hydrochloride IP 1000mg

1 Tablet

M/s Windlas Biotech Limited / Wockhardt Limited

9.82

30.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 500mg

1 Tablet

M/s Sun Pharma Laboratories Limited

18.34

31.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 1000mg

1 Tablet

M/s Sun Pharma Laboratories Limited

20.02

32.

Sitagliptin Phosphate & Metformin Hydrochloride Extended

Release Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (As Extended

Release form)

1 Tablet

M/s Sun Pharma Laboratories Limited

19.81

33.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 500mg

1 Tablet

M/s Exemed Pharmaceuticals / M/s Eris Life Sciences Limited

18.34

34.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 1000mg

1 Tablet

M/s Exemed Pharmaceuticals / M/s Eris Life Sciences Limited

20.02

35.

Sitagliptin Phosphate & Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg

Metformin Hydrochloride IP 850mg

1 Tablet

M/s Exemed Pharmaceuticals / M/s Eris Life Sciences Limited

19.14

36.

Linagliptin & Metformin Hydrochloride Tablets

Each Film Coated tablet contains:

Linagliptin 2.5 mg

Metformin Hydrochloride 500 mg

1 Tablet

M/s Mediforce Healthcare Pvt. Ltd.

/ M/s Mankind Pharma Ltd.

14.65

37.

Linagliptin & Metformin Hydrochloride Tablets

Each film coated bilayered tablet contains:

Linagliptin 2.5mg Metformin Hydrochloride IP 500mg

1 Tablet

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

Laboratories Ltd.

14.65

38.

Linagliptin & Metformin Hydrochloride Tablets

Each film coated bilayered tablet contains:

Linagliptin 2.5mg Metformin Hydrochloride IP 1000mg

1 Tablet

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

Laboratories Ltd.

16.33

39.

Linagliptin & Metformin Hydrochloride Tablets

Each Film Coated tablet contains:

Linagliptin 2.5 mg

Metformin Hydrochloride IP 1000 mg

1 Tablet

M/s Mediforce Healthcare Pvt. Ltd.

/ M/s Mankind Pharma Ltd.

16.33

40.

Linagliptin & Metformin Hydrochloride Tablets

Each Film Coated tablet contains:

Linagliptin 2.5 mg Metformin Hydrochloride IP 850 mg

1 Tablet

M/s Mediforce Healthcare Pvt. Ltd.

/ M/s Mankind Pharma Ltd.

15.45

Note:

(a) The manufacturer of above mentioned formulations i.e. "new drug" under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove.
(b) 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.
(c) 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.
(d) 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.
(e) 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.
(f) 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.
(g) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.
To view the official notices, click on the link below:

https://medicaldialogues.in/pdf_upload/9th-may-222115.pdf

https://medicaldialogues.in/pdf_upload/9th-may-1-222116.pdf

Read also: Ahead Of Linagliptin Going Off-Patent, NPPA Fixes Retail Price Of Its FDC With Metformin

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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