On Thursday, pharma company Zydus Cadila announced that it has received approval from United States Food and Drug Administration (USFDA) for its supplemental abbreviated new drug application (SANDA) for Doxycycline Injection USP, 100mg/vial.
The product is set to be manufactured at Jarod, Vadodara, the company's injectible facility, which is equipped with manufacturing lines that can handle both liquid and lyophilised products based on vials and cartridges presentation.
The approval of Doxycycline USP marks the company's first product approval at the second combined liquid plus lyophilised vials injectable line at the Jarod facility. The facility is important for the company's US injectible portfolio as five such ANDAs have been approved and another six have been filed and are awaiting approval. The company also stated that it has plans to file further ANDAs and NDAs from this facility.
The group has 293 approvals presently and has filed over 390 ANDAs till date, since the commencement of its filing process in FY 2003-04.
Cadila Healthcare Limited manufactures and markets healthcare solutions ranging from active pharmaceutical ingredients, formulations, diagnostics, vaccines, health and dietetic foods, animal healthcare to cosmeceuticals. Its products are available in capsules, tablets, liquids, dry syrups, injections, powders, ointments and granules.
At 12.40 pm on Thursday, the stock of Cadila Healthcare was trading at Rs 355.20, up by 0.25 per cent or Rs 0.90 per share. The 52-week high is Rs 383.65 and the 52-week low is recorded at Rs 206.45 on BSE.