Zydus Cadila gets USFDA nod to market generic anti-diabetic drug

Drug firm Zydus Cadila Thursday said it has received tentative nod from the US health regulator to market generic Sitagliptin and Metformin Hydrochloride extended-release tablets used for controlling blood sugar levels

Press Trust of India March 14, 2019 17:32:56 IST
Zydus Cadila gets USFDA nod to market generic anti-diabetic drug
  • The company has received the tentative approval from the USFDA to market Sitagliptin and Metformin Hydrochloride extended-release tablets

  • The tablets will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said

  • Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 331.45 per scrip on BSE, down 0.02 percent from its previous close

New Delhi: Drug firm Zydus Cadila Thursday said it has received tentative nod from the US health regulator to market generic Sitagliptin and Metformin Hydrochloride extended-release tablets used for controlling blood sugar levels.

The company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market Sitagliptin and Metformin Hydrochloride extended-release tablets in the strength of 50 mg/500 mg, 50 mg/1,000 mg and 100 mg/1,000 mg.

Zydus Cadila gets USFDA nod to market generic antidiabetic drug

Image used for representational purposes only. AFP.

The product is the generic version of Janumet XR tablets, it added.

The tablets will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said.

The product contains two oral anti-diabetic medications used in the management of type 2 diabetes, it added.

The group now has 255 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.

Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 331.45 per scrip on BSE, down 0.02 percent from its previous close.

Updated Date:

also read

Zydus Cadila gets FDA approval to sell anti-depressant drug in US
Business

Zydus Cadila gets FDA approval to sell anti-depressant drug in US

The Ahmedabad-based group has now 87 approvals from the USFDA and so far it has filed 216 abbreviated new drug applications (ANDAs) since the commencement of filing process in FY 2003-04.<br /><br />

Zydus Cadila gets USFDA approval for diabetes treatment drug Nateglinide
Business

Zydus Cadila gets USFDA approval for diabetes treatment drug Nateglinide

Nateglinide tables is an anti-diabetic agent used in management of type-2 diabetes mellitus

Biocon Biologics receives EIR from USFDA for two manufacturing facilities in Bengaluru
Business

Biocon Biologics receives EIR from USFDA for two manufacturing facilities in Bengaluru

Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., said on Thursday it has received the Establishment Inspection Report (EIR) from the USFDA (the United States Food and Drug Administration) for the pre-approval inspection at two of its biologics manufacturing facilities in Bengaluru