Zydus Lifesciences to manufacture Sagent Pharma Caffeine Citrate Oral Solution
The product is indicated for the short-term treatment of a breathing problem (Apenia) in premature infants.
Ahmedabad: Zydus Lifesciences's (Formerly known as Cadila Healthcare Ltd.), an innovation-led global lifesciences company announced that it will be manufacturing 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, India.
The company 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 (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.
A Prior Approval Supplement (PAS) is an application which seeks to make changes to an already approved application, such as an Abbreviated New Drug Application (ANDA), which is used by the USFDA to approve generic drugs.
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.
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