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Western Medicine Preparation Exportation of Chinese Pharmaceutical Enterprises to the U.S.(1)
Xiaoyaowan
September 19, 2018
278 ANDA Approvals! A Quick Look at the Western Medicine Preparation Exportation of Chinese Pharmaceutical Enterprises to the U.S.
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Strides Pharma receives USFDA nod for two key ANDAs
biospectrumasia
August 24, 2018
The USFDA also granted Strides’ request to designate the drug product under these ANDAs as a Competitive Generic Therapy (CGT)
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Glenmark Pharma receives ANDA approval for nitroglycerin sublingual tablets
expressbpd
September 21, 2017
IMS Health estimates annual sales of approx $112.7 million for these three strenghts of Nitrostat® Sublingual Tablets
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US FDA hikes fee for processing ANDA by $1 lakh for FY18
expressbpd
September 01, 2017
The hike was made under Generic Drug User Fee Amendments of 2017 (GDUFA II)
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Glenmark receives ANDA approval for Triamcinolone Acetonide Ointment
expressbpd
August 24, 2017
It is the generic version of Kenalog Ointment, 0.1 per cent, of Mylan Pharmaceuticals
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Glenmark Pharma receives tentative ANDA approval for solifenacin succinate tabs
expressbpd
June 26, 2017
According to IMS Health, the Vesicare tablets, 5 mg and 10 mg market achieved annual sales of approximately $1.1 billion
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CPhI expert says quicker approvals for ANDA’s would lower drug costs
europeanpharmaceuticalreview
April 27, 2017
Girish Malhotra, President of EPCOT International, and CPhI Worldwide Annual Industry Report member, discusses the necessity of time reduction for ANDA (Abbreviated New Drug Application) approvals...
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Glenmark receives ANDA approval for Fenofibrate caps
financialexpress
April 11, 2017
The product will be available in USP 67 mg, 134 mg and 200 mg
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Amring Pharmaceuticals Acquires Six ANDAs
americanpharmaceuticalreview
March 13, 2017
Amring Pharmaceuticals has acquired six ANDAs from Luitpold Pharmaceuticals, Inc. and AlphaForce, L.L.P., a joint venture between Luitpold Pharmaceuticals, Inc. and Alphagen Laboratories Inc. Acquired ANDAs include niche otic and ophthalmic pharmaceutica
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Custopharm Acquires Two ANDA Pharmaceutical Products From Perrigo
firstwordpharma
January 05, 2017
Custopharm, Inc., a U.S. leader in generic injectable products, announced today that it has acquired two paragraph IV abbreviated new drug application (ANDA) products from Perrigo Company plc.