The Hindu Business Line : Strides Arcolab plant gets USFDA nod

Bangalore, March 12 Strides Arcolab Ltd has announced that its Bangalore-based penicillin injectables plant has been approved by the US Food and Drug Administration.

One ANDA (drug submission) each has been approved by the USFDA and the Canadian regulator for entry to their respective markets. The penicillin facility manufactures sterile injectables in dry powder vials. Strides said the approval is an important milestone as the plant supports important submissions being made for the US market.

Canadian nod

Tazo Pip sterile injection ANDA (abbreviated new drug application) becomes the second ANDA to be approved by Health Canada.

Tazo Pip — a generic version of Wyeth’s Tazocin — is licensed in three presentations to an undisclosed partner in Canada and will be launched immediately.

Strides said Tazo Pip has a Canadian market size of around $20 million (Rs 80 crore) and global sales of over $500 million (around Rs 1,000 crore).

Mr Arun Kumar, Vice-Chairman and Group CEO of Strides Arcolab, said, “Tazo Pip is an extremely important sterile product and we are further delighted that we are amongst the first wave of approvals for this significant product.”

The USFDA has approved Tobramycin 40 mg/ml, which Strides has licensed to its joint venture, Akorn-Strides LLC.

Tobromycin was among 22 sterile submissions made to USFDA and the second drug to be approved for the US market.

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page