India Pharma Outlook Team | Wednesday, 13 April 2022
Zydus Lifesciences announced that it will be producing and supplying Sagent’s caffeine citrate oral solution in the strength of 60 mg per 3 mL (20 mg per mL) Single-dose Vial (US RLD: CAFCIT) from its injectables facility at Jarod, Gujarat. The firm announced that it received the Prior Approval Supplement (PAS) Approval from the US Food and Drug
Administration (USFDA), which allows for a site transfer and manufacturing of the drug at Jarod. This product is indicated for the short-term treatment of a breathing problem (Apnoea) in premature infants.
Caffeine blocks certain proteins (adenosine receptors) which leads to improved breathing in these infants. Sagent Pharmaceuticals, Inc. (Sagent), a Nichi-Iko Group Company, is a specialty pharmaceutical company focused on developing, manufacturing, sourcing, and marketing pharmaceutical products for the North American market, with a specific emphasis on injectables. Prior Approval Supplement (PAS) is an application that seeks to make changes to an already accepted application, such as an Abbreviated New Drug Application (ANDA), which is used by the USFDA to approve generic drugs.
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