Ind-Swift Laboratories has received the US Food & Drug Administration (USFDA) nod for two more DMFs - Temozolomide and Telmisartan - filed by it in US. Besides commercially supplying four molecules to the US, the company has hitherto filed 20 DMFs with the USFDA, of which all have been approved. Temozolomide is an anti-neoplastic drug with market size of $700 million and Telmisartan is a drug for hypertension with market size worth $1.6 billion, the company has a strong basket of 40 plus products across 16 therapeutic segments.
The company’s subsidiary in the US, which has been operational since 2005, is playing a significant role in boosting the company’s business in the US market as it has forged key contracts with leading US generic companies.
The company has so far filed 302 DMFs with various regulatory authorities, including 4 DMFs filed in Japan. Also, 124 patents have been filed, of which one has been granted for cardiovascular drug.
Recently, the company had received PMDA approval (Pharmaceutical & Medical Devices Agency) from Government of Japan for Pioglitazone and Risedronate Sodium to be manufactured at its facilities in Derabassi (Punjab). With this achievement, the company has become the first Indian company to get Japanese Government approval without any observations.
Ind-Swift Laboratories is a part of the Ind-swift Group and is based at Chandigarh, India. The company is engaged in manufacturing of Active Pharmaceutical Ingredients (API).
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