Lupin Gets Marketing Approval for Generic Vibramycin Injection

Lupin Gets Marketing Approval for Generic Vibramycin Injection

By, Admin 18 March 2024

Lupin gets US FDA marketing approval for generic Vibramycin for injection

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for doxycycline for injection USP, 100 mg/vial (single-dose vial), to market a generic equivalent of Vibramycin for injection, 100 mg/vial, of Pfizer Inc. The product will be manufactured at Lupin’s Nagpur facility in India. 

Doxycycline Indication

  • Doxycycline for injection USP is indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline and other antibacterial drugs. 
  • Doxycycline for injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 

Annual Sale 

Doxycycline for injection USP (RLD Vibramycin) had estimated annual sales of USD 47 million in the US (IQVIA MAT January 2024).

About Lupin

  • Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 
  • The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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