Zydus Lifesciences is planning to manufacture and supply 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, India. The company 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 (Apnea) 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.
Zydus Lifesciences is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.
