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Pharmaceutical industry

Strides Arcolab Secures US FDA Approval for Generic Gemcitabine Injection

Strategic Insights

— 1 min read

Strides Arcolab, a leading manufacturer and exporter of pharmaceuticals, has received approval from the United States Food and Drug Administration (US FDA) for its generic version of the chemotherapy drug Gemzar, marketed by Eli Lilly and Company. The approval marks the company's foray into the US Oncology market and strengthens its partnership with Pfizer in the global oncology space. The generic drug, Gemcitabine for Injection USP, is available in 200mg, 1 gm, and 2 gm dosage forms, targeting a US market valued at approximately $700 million as of March data.

Key Takeaways:

  • Strides Arcolab has secured US FDA approval for its generic Gemcitabine for Injection USP, a generic version of Eli Lilly's Gemzar.
  • The approval is a significant milestone for the company, marking its entry into the US Oncology market.
  • The generic drug is available in 200mg, 1 gm, and 2 gm dosage forms and is prescribed for the treatment of ovarian cancer, breast cancer, and non-small cell lung cancer.
  • The US market for Gemcitabine is valued at approximately $700 million as per March data.
  • Strides Arcolab's Oncology portfolio, which includes Gemcitabine, was licensed to Pfizer.
  • The company's commercialization of Gemcitabine will strengthen its partnership with Pfizer in the global oncology space.
  • Strides Arcolab is one of the first wave players to receive US FDA approval for 200mg, 1 gm, and 2 gm dosage forms.

Statistics:

  • US market value for Gemcitabine: approximately $700 million (as of March data)
  • Dosage forms approved by US FDA: 200mg, 1 gm, and 2 gm
  • Pump price for Gemcitabine in the US (as of March 2023): Not specified in the source material
  • Number of dosage forms approved by US FDA: 3
  • Number of companies approved for 200mg, 1 gm, and 2 gm dosage forms: Strides Arcolab was one of the few companies to receive this approval.

Sources:

  • "Strides Arcolab gets USFDA nod for Gemcitabine for Injection" - Contify.com
  • Strides Arcolab website - *Initiation of Commercialization of Gemcitabine for Injection USP* - 2011
  • "Strides Arcolab receives USFDA approval for Polymyxin B for injection" - Contify.com

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