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The Dollar Business Bureau  Despite many hurdles, pricing pressures and competition from other major pharma producing countries, India’s pharma exports to the US will in all likelihood increase in 2017-18. Drugs worth $50bn are expected to become off-patented this year giving enough room for pharma exports to get a boost, a report by Care Ratings revealed.  The Indian Pharma industry is likely to face stiff competition from other countries to get Abbreviated New Drug Application(ANDA) approval. Other than this the pricing pressure is likely to increase in the generics market due to the consolidation of distribution channels and increase in competition the report detailed. However due to gain in the sales of generics drugs with branded drugs going off patent during 2017-19, will ...

The Dollar Business Bureau Indian Pharma exports to the US may increase in 2017-18 despite pricing pressure and stiff competition. A report released by Care Ratings said that $50 billion worth of drugs are expected to become 'off-patent' in the current year giving hope to the Indian Pharma export market. "The pharma export volumes from India to US, however, are expected to rise. This will be backed by about $55 billion expected sales gain to generics drugs on account of branded drugs going off patent during 2017-19 which will create an opportunity for CRAMS segment. We expect growth rate for CRAMS (Contract Research and Manufacturing Services) to be higher compared to average growth rate of the industry. These factors are likely to support pharma exports from India," ...

The Dollar Business Bureau Jubilant Life Sciences, global pharma and life sciences major, has announced on Wednesday that it has got the final ANDA (Abbreviated New Drug Application) approval for generic drugs, used in the treatment for hypertension. “Jubilant Life Sciences has got final ANDA (Abbreviated New Drug Application) approval for Felodipine Extended-Release Tablets USP, 2.5 mg, 5 mg, and 10 mg, the generic version of Plendil Tablets of AstraZeneca, which is used for the treatment of hypertension,’ the company said in a statement. As of June 30 this year, the global pharmaceutical and life sciences company had an overall of 770 filings for Oral Solids, out of which 578 filings have been approved in several regions around the world. This consists of 70 ...

The Dollar Business Bureau The growth of Indian pharmaceutical exports is likely to come down to 10-12% y-o-y during the next five years, when compared to the growth of 19% in the past ten years, as per CRISIL Research. Due to the decreasing value of off-patent drugs and increasing pressure on prices, the exports of generics have less impact on the growth of the pharma industry, it said. According to CRISIL Research, Indian pharma companies must enhance their investments in new molecules for sustainable growth till 2020 and beyond. The domestic companies shall also prepare a roadmap related to the growth of lower generics. In the last 10 years, process chemistry skills have helped pharma companies to clone off-patent drugs by tweaking ...

The Dollar Business Bureau  Mumbai-based Glenmark Pharmaceuticals on Monday announced that it has got ANDA approvals from the United States Food and Drug Administration (USFDA) for its two oral contraceptives - Levonorgestrel tablet, 1.5 mg and Drospirenone and Ethinyl Estradiol tablets, 3 mg/0.03 mg. “Glenmark Pharmaceuticals Inc. has been granted final approval by the USFDA for Drospirenone and Ethinyl Estradiol tablets USP, 3 mg/0.03 mg, the generic version of Yasmin tablets of Bayer HealthCare Pharmaceuticals Inc. (Bayer) and for Levonorgestrel tablet, 1.5 mg, the generic version of Plan B One-Step tablet of Teva Branded Pharmaceutical Products R&D, Inc., for over-the-counter (OTC) use as recommended in the submitted labeling,” Glenmark said in a press release. The drug major, however, cautioned the risk ...

 The Dollar Business Bureau Aurobindo Pharma Ltd. on Friday announced that it has earned the US Food & Drug Administration (USFDA) nod to produce and market Dexmedetomidine Hydrochloride injection. This drug is used as a sedation of non-intubated patients who are required to follow surgical or various other types of procedures. The injection will be launched in April-July this year. “The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Precedex Injection, 200 mcg/2 mL, of Hospira, Inc.,” Aurobindo Pharma said in a statement. “The product has an estimated market size of $59.1 million for the twelve months ending January 2016,” the company said. The company’s Unit IV manufacturing facility has so far secured 27 ANDA ...

 The Dollar Business Bureau Hyderabad-based Aurobindo Pharma Ltd. on Tuesday announced it has received the US Food & Drug Administration (USFDA) approval to manufacture and market Ibandronate Sodium Tablets 150 mg – used in the treatment and prevention of osteoporosis in postmenopausal women. This new product is expected to be launched sometime in April – June 2016-17. “The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Boniva Tablets of Hoffman-La Roche Inc,” Aurobindo Pharma Ltd. said in a statement. Ibandronate Sodium Tablets 150 mg has an estimated market size of 55 million for a period of twelve months ending January 2016. With the approval of this new product, Aurobindo Pharma’s Unit VII formulation facility in ...

Glenmark currently has 106 products authorised for distribution in the US marketplace and 62 ANDAs pending approval with the USFDA The Dollar Business Bureau : On Tuesday, the Ministry of Finance approved Glenmarks FDI proposal for allotment of 103,000 equity shares to the foreign nationals employee worth $3.34 crore   Mumbai-based Glenmark Pharma Ltd. on Wednesday announced that it has received tentative approval from the United States Food & Drug Administration (USFDA) for its Azelaic Acid Gel used for the treatment of skin inflammation. Glenmark will market this product upon receiving final approval of its Azelaic Acid Gel, 15% ANDA. The patent listed in the Orange Book for Finacea Topical Gel, 15% is scheduled to expire on November 18, 2018, Glenmark Pharma said in ...