Indian pharmaceutical companies and their subsidiaries maintained the momentum in respect of securing ANDA approvals from US FDA during the first half ended June 2013. These companies received 87 final approvals for ANDAs as well as 25 tentative approvals. The total number of ANDAs approved by US FDA during the first half stood at 211 and total tentative approvals are 47. This worked out to 41 per cent and 53 per cent approvals secured by the Indian pharmaceutical companies. The similar trend was exhibited in the corresponding period of last year also. The investments in Research & Development (R&D) will offer more and more approvals in the current year. This will help to boost the top line as well as bottom line in the current year.

Aurobindo Pharma and Sun Pharmaceuticals have maintained approval rate and got highest approval of 15 ANDAs during the first half of 2013. This was followed by Lupin 11, Dr Reddy's Laboratories 7, Emcure Pharms 6, Claris LifeSciences and Glenmark Generic 4 each. Further, Alembic Pharma, Alkem Laboratories, Sagent Pharma and Zydus Pharma got 3 ANDA approvals each.

During the full year ended December 2012, Indian pharma companies got 178 ANDAs approval from US FDA as against total approvals of 476, which worked out to 37.4 per cent of the total. Aurobindo received highest approval for 24 ANDAs during the year ended December 2012 and this was followed by Dr Reddy's Laboratories 19 ANDAs, Onco Therapies 16 ANDAs and Sun Pharma 13 ANDAs. The total tentative approvals during the period worked out to 42 from total tentative approval of 94 ANDAs. With higher approvals for ANDAs the following companies are well set to achieved better performance in the current year.

With highest number of ANDA approvals, Aurobindo Pharma has improved its working during the year ended March 2013 and its consolidated net sales increased by 27.1 per cent to Rs.5,783 crore from Rs.4,551 crore in the previous year. Net sales includes dossier income of Rs.75.98 crore as against Rs.59.85 crore. Aurobindo's EBDITA moved up by 44.5 per cent to Rs.917.61 crore from Rs.634.84 crore. Its interest cost went up by 27.8 per cent to Rs.131.33 crore from Rs.102.78 crore. The company posted forex gain of Rs.163.44 crore as compared to Rs.223.30 crore in last year. Due to this, its profit before tax and exceptional items increased to Rs.374.10 crore from Rs.108.23 crore.

Sun Pharmaceuticals and it's subsidiary Caraco Pharma has also secured total 15 ANDAs from US FDA during the first half ended June 2013. Its consolidated R&D expenditure for the year ended March 2013 was at Rs.676 crore, which worked out to six per cent of sales. It launched 25 new products during the financial year 2012-13. Its US sales increased by 56 per cent to US$ 1,132 million. Its API business continues to be largely used for vertical integration on key products. It filed 239 DMF/ CEP applications and received 168 approval so far.

Sun Pharma filed 22 ANDAs during the year and its cumulative total reached at 449 ANDAs and it received approval for 20 products during 2012-13. Its cumulative approvals stand at 311 while ANDAs for 138 products now await US FDA approval, including 17 tentative approvals. It submitted total 814 patent and received 457 patents.

Lupin's revenue R&D expenditure for the full year ended March 2013 increased by 35.8 per cent to Rs.710 crore from Rs.523 crore. It filed 21 ANDAs and received 14 approvals from the US FDA during 2012-13. Cumulative ANDA filings with the US FDA stood at 176 with the company having received 78 approvals to date. It also filed three MAAs with European regulatory authorities and has received four approvals in the last quarter ended March 2013 and cumulative filings with European authorities now stand at 53 and received 38 approvals. The US brands business contributed 21 per cent of total US sales whereas the generics business contributed 79 per cent. It launched 10 new products in the US market in the FY'2013. Lupin is now the market leader in 24 products out of the 46 products marketed in the US generic market.

For the full year ended March 2013, Lupin's consolidated net sales increased by 36 per cent to Rs.9,462 crore from Rs.6,960 crore in the previous year. Its other operating income also grew by 46.3 per cent to Rs.180 crore from Rs.123 crore. The net profit moved up by 51.5 per cent to Rs.1,314 crore from Rs.868 crore.

Dr Reddy's Laboratories launched 78 new generic products and filed 56 new product registrations. Further, it filed 47 DMFs globally and its cumulative total reached at 577 DMFs as at the end of March 2013. It also filed 18 ANDAs and one NDA, and its cumulative figure reached 65 ANDA pending with US FDA for approval.

Glenmark received approval for nine ANDAs during 2012-13 and it completed successful launch of five products. The company has a pipeline of five NCE and NBE molecules in clinical trials including the in-licensed molecule ''Crofelemer.'' The Regulatory Agency of Japan has approved its Anklelshwar API facility during the year and major inroads were made in to Japan with three new products filings.


FINAL & Tentative ANDAs Approval in Jan-June 2013