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The company "has received Abbreviated New Drug Application (ANDA) final approval for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg," Jubilant Life Sciences said in a BSE filing.
Duloxetine is a bioequivalent generic version of Cymbalta delayed release capsules and part of an ever growing portfolio of products that the company has developed for the US market.
Granules India is looking at expanding its business to new geographies. The company is targeting 30-40 percent bottomline growth in FY18, C Krishna Prasad, MD of company said.
Biotechnology major Biocon reported 19.8 percent rise in revenue to Rs 796.2 crore year-on-year and margins grew to 25.2 percent from 21.2 percent in the second quarter of FY17. The company‘s standalones sale grew 17 percent in Q2.
"US FDA has approved Abbreviated New Drug Application (ANDA) for Ibuprofen tablets USP, 200 mg (OTC) filed by Granules India Ltd," the company said in a BSE filing.
The company has "received Abbreviated New Drug Application (ANDA) final approval for Darifenacin Extended-Release Tablets, 7.5 mg and 15 mg, the generic version of Enablex of Allergan Plc, which is used for the treatment of urinary incontinence", Jubilant Life Sciences said in a BSE filing.
US FDA inspected the Goa plant II for five days starting from August 31. Injectable Abbreviated New Drug Application (ANDA) filings had triggered the US FDA to inspect the plant.
As on June 30, 2016, the company had a total of 770 filings for oral solids of which 578 have been approved in various regions globally.
The company has received abbreviated new drug application (ANDA) final approval for Telmisartan tablets, USP 20, 40 and 80mg, the generic version of Micardis tablets of Boehringer Ingelheim Pharmaceuticals Inc., which is used for the treatment of hypertension.
While the first quarter earnings have been mixed, earnings in second half of FY17 will be driven by monsoon and consumption, says Anup Maheshwari of DSP Blackrock Investment Managers.
The company has received final approval of ANDA containing a paragraph IV certification filed with the US Food and Drug Administration (USFDA) for generic versions of Tamiflu oral capsules, 30 mg, 45 mg and 75 mg.
In a BSE filing, Sun Pharma said: "One of its subsidiaries has received final approval from USFDA for its Abbreviated New Drug Application (ANDA) for generic version of Crestor, Rosuvastatin Calcium tablets.
The company's marketing partner, Mylan Inc., has received a tentative approval for its abbreviated new drug application (ANDA) for Sorafenib Tablets, 200mg, with the USFDA.
The company has announced that USFDA has granted approval for an Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride extended-release tablets USP 500 mg and 750 mg.
"The company has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Quetiapine Fumarate tablets," Unichem Laboratories said in a filing to BSE.
Mayuresh Joshi of Angel Broking is positive on Sun Pharmaceutical Industries.
The company and its US arm Glenmark Pharmaceuticals Inc have entered into a settlement agreement with Forest Laboratories LLC, Forest Laboratories Holdings Ltd and Royalty Pharma Collection Trust to settle the litigation.
Drug firm Aurobindo Pharma has received final approval from the US health regulator to manufacture and market its oral contraceptive, Levonorgestrel tablets.
The company has received final abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Irbesartan tablets, Unichem Laboratories said in a filing to the BSE.
"The subsidiary today has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for generic version of Gleevec, imatinib mesylate tablets 100mg and 400mg," says the country's largest drug maker in its filing.
It has received approval for Paroxetine tablets USP, 10 mg, 20 mg, 30 mg and 40 mg, the generic version of Paxil Tablets, 10 mg, 20 mg, 30 mg, and 40 mg (of Apotex), which is used as an antidepressant.
C Krishna Prasad, MD, Granules India says margins in contract research and manufacturing services (CRAMS) business is relatively high and expects 30-35 percent of capacity utilization in the same.
Quoting IMS data, Aurobindo Pharma said the approved product has an estimated market size of USD 80 million for the twelve months ended September 2015.
The product is a generic version of Forest Laboratories' Namenda tablets in the same strengths, it added.
Unichem's product is therapeutically equivalent to Forest Laboratories Inc's Namenda tablets, it added.
