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Zydus Lifesciences bags USFDA nod for Sildenafil for Oral Suspension

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-10-01T12:10:27+05:30  |  Updated On 1 Oct 2022 6:40 AM GMT
Zydus Lifesciences bags USFDA nod for Sildenafil for Oral Suspension

The drug will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh, India.

Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) today announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to market Sildenafil for Oral Suspension USP 10 mg/ml USRLD: Revatio.Sildenafil for oral suspension is used to treat high blood pressure in the lungs (pulmonary hypertension). It works...

Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) today announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to market Sildenafil for Oral Suspension USP 10 mg/ml USRLD: Revatio.

Sildenafil for oral suspension is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in the lungs, which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows the heart and lungs to work better and improves the ability to exercise.

The drug will be manufactured at the group's formulation manufacturing facility at Baddi, Himachal Pradesh, India.

Read also: Zydus Lifesciences US arm, BridgeBio Pharma get European Commission nod for NULIBRY to treat MoCD Type A

Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States, according to IQVIA data (IQVIA MAT Aug 2022). The group now has 324 approvals and has so far filed over 428* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported that Zydus Lifesciences Limited had received final approval from the United States Food and Drug Administration (USFDA) to market Bisoprolol Fumarate Tablets USP 5 mg and 10 mg.

Read also: Zydus Lifesciences bags USFDA nod for BP drug Bisoprolol Fumarate

Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and in the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
Read also: Zydus Lifesciences launches cancer drug Lenalidomide in US
Zydus Lifesciences Zydus Lifesciences news Cadila Healthcare USFDA Sildenafil blood pressure pulmonary hypertension Baddi facility BP drug 
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor 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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