Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final
approval from the United States Food and Drug Administration (USFDA) to market
Acetaminophen Injection, 1,000 mg/100 mL (10 mg/mL) single-dose vials (USRLD: Ofirmev).
Acetaminophen injection is indicated to relieve mild to moderate pain and to reduce fever. It is
also used in combination with opioid (narcotic) medications to relieve moderate to severe pain.
The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near
Acetaminophen injection had annual sales of USD 72 mn in the United States, according to
IQVIA data (IQVIA MAT Aug 2022).
The group now has 330 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 USFDA to market Ketorolac Tromethamine Tablets USP, 10 mg (USRLD: Toradol). Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
Zydus group is headquartered in Ahmedabad, India. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India, the US, and Brazil.
Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.