Monthly Dose March 2019 Monthly Dose July 2021
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MONTHLY DOSE MARCHJULY 2021 2019 News for the Month Zydus Cadila applies for emergency use nod for Covid-19 vaccine Alembic Pharma gets USFDA nod for generic Nitrofurantoin capsules Zydus Cadila gets USFDA nod to market generic HIV infection treatment tablets Laurus Labs receives licence from DRDO to manufacture and market Covid drug 2DG Cadila Healthcare arm recalls 21,240 bottles of diabetes drug in US Torrent’s nasal spray exempted from price cap for five years Morepen Labs starts production of test batch of Sputnik V vaccine Dr. Reddy's bullish on OTC products sale through Amazon, others in US Glenmark to conduct Phase III trial nasal spray meant to treat Covid-19 Alembic Pharma gets USFDA nod for cancer treatment drug FDC launches Favipiravir oral suspension to treat Covid-19 in India SII to begin manufacturing Sputnik V vaccine in September, announces RDIF Lupin launches generic antifungal product in US market Zydus Cadila seeks approval for its needle-free Covid vaccine ZyCOV-D Cadila arm completes sale of animal health business for Rs2,921cr Company Venus Remedies launches consumer healthcare division USFDA issues import alert on Jubilant Pharmova's Roorkee plant Alkem looks for partnerships, in-licensing deals to bolster presence in US market Steriline Supplies Shilpa Medicare with Pilot Line for injectable oncology drugs EMA grants Orphan Drug Designation to Cadila's Saroglitazar Mg for treating patients with PBC Zydus Cadila gets tentative nod from USFDA to market cancer drug Bharat Biotech commits to supply 500 million doses of Covaxin to Centre for immunisation programme Biocon Biologics gets licence from Adagio Therapeutics for antibody treatment of Covid-19 BDR Pharma inks license agreement with DRDO to produce Covid-19 drug 2-DG Sun Pharma, Cassiopea SpA ink license & supply agreements for acne treatment drug Winlevi Made in India Sputnik V to be available during September-October: Dr. Reddy's Shilpa Medicare receives WHO approval for HIV drug Alkem Laboratories’ USFDA inspection at Taloja facility ends with 'zero' observations Biocon Biologics interchangeable insulin Semglee gets USFDA approval Local firms got voluntary license for more drugs during pandemic Revenue growth of drug firms in current fiscal to be in the range of 7-9%: Icra NPPA approves price rise of 50% for carbamazepine, ranitidine, ibuprofen India's most purchased drugs in the last decade are for cardiac ailments, diabetes Remdesivir, hydroxychloroquine show no antiviral effect against Covid-19: Study Industry Govt exempts raw material imports of Amphotericin B and Covid testing kits till September end Pfizer and BioNTech announce collaboration with Biovac to manufacture and distribute Covid-19 vaccine doses within Africa Global Vabiotech confirms production of first batch of Sputnik V vaccine in Vietnam Source: Media Reports and Company Press Releases Tentative ANDA Approvals: Company API Strengths Indications Brand (Company) Mkt Size Unichem Sitagliptin 25/50/100mg Indicated as an adjunct to diet and Januvia (Merck Sharpe and - Tablets exercise to improve glycemic Dohme Corp) control in adults with type 2 diabetes mellitus Cadila Ibrutinib Tablets 140/280/420/560mg Used to treat certain cancers Imbruvica Tablets (AbbVie USD3.7bn (annual Company) sales, Dec 2020) Source: Media Reports and Company Press Releases Final ANDA Approvals: Company API Strengths Indications Brand (Company) Mkt Size Alembic Nitrofurantoin 25/100mg Indicated for the treatment of Macrodantin Capsules USD23mn Capsules urinary tract infections (Alvogen Malta Operations Ltd) Alembic Erlotinib Tablets 25/100/150mg Used in the treatment of cancer Tarceva Tablets (OSI USD37mn Pharmaceuticals, LLC.) Caplin Point Sumatriptan Injection 6mg/0.5mL (12mg/ Indicated in adults for acute IMITREX Injection USD5mn mL) Single dose treatment of migraine with or (GlaxoSmithKline, USA.) (annual sales) Vials without aura, and acute treatment of cluster headache Cadila Fulvestrant Injection 250mg/5mL Used alone or in combination with Faslodex Injection USD407mn (50mg/mL) per other drugs to treat a certain type of (AstraZeneca) (annual sales, single-dose hormone receptor positive June, 2020) pre-filled syringe Source: Media Reports and Company Press Releases BSE Health Care Index Price Performance BSE Health Care Index Price Performance Change Change Companies Price Companies Price 1 M 6 M 12 M 1 M 6 M 12 M Aarti Drugs Ltd 668 -5.6% -0.9% -60.9% IPCA Laboratories Ltd 2102 3.8% 13.4% 20.5% Abbott India Ltd 19086 13.6% 34.0% 28.1% J.B.Chemicals & Pharma Ltd. 1812 9.0% 81.1% 149.4% Ajanta Pharma Ltd 2289 6.7% 29.5% 51.4% Laurus Labs Ltd 641 -5.7% 85.6% -19.0% Albert David Ltd 546 11.6% 28.2% 35.9% Lincoln Pharmaceuticals Ltd 349 -0.9% 56.5% 77.4% Alembic Ltd 121 -4.4% 28.5% 52.8% Lupin Ltd 1107 -3.7% 9.9% 24.4% Alembic Pharmaceuticals Ltd 788 -19.9% -17.3% -20.1% Marksans Pharma Ltd 82 -5.1% 48.8% 116.5% Alkem Laboratories Ltd 3455 8.1% 15.0% 35.7% Max Healthcare Institute Ltd 297 16.9% 83.3% - Apollo Hospitals Enterprise Ltd 4034 11.5% 57.5% 135.1% Metropolis Healthcare Ltd 2845 0.7% 38.0% 78.3% Aster DM Healthcare Ltd 163 5.8% 3.1% 24.5% Morepen Laboratories Ltd 65 4.1% 135.9% 198.4% AstraZeneca Pharma India 3371 -6.6% -7.2% 1.7% Narayana Hrudayalaya Ltd 490 -0.3% 10.3% 66.5% Aurobindo Pharma Ltd 917 -5.0% 1.2% 11.8% Natco Pharma Ltd 1024 -9.3% 14.7% 36.7% Biocon Ltd 387 -4.4% 3.9% -4.2% Neuland Laboratories Ltd 1986 -7.3% 54.4% 187.8% Bliss GVS Pharma Ltd 108 0.8% -42.0% 1.4% Novartis India Ltd 959 11.3% 46.6% 56.2% Cadila Healthcare Ltd 586 -9.2% 29.8% 60.3% Panacea Biotec Ltd 321 -13.1% 65.9% 63.5% Caplin Point Laboratories Ltd 884 32.7% 92.2% 116.8% Pfizer Ltd (India) 5871 3.5% 26.6% 38.7% Cipla Ltd 920 -5.3% 11.5% 34.2% Poly Medicure Ltd 982 -3.4% 93.9% 149.3% Dishman Carbogen Amics Ltd 209 -1.9% 70.4% 11.6% Procter & Gamble Health Ltd 5356 -4.3% -24.7% 28.9% Divi's Laboratories Ltd 4905 11.3% 45.5% 91.5% RPG Life Sciences Ltd 509 12.9% 26.3% 60.7% Dr. Reddy's Laboratories Ltd 4713 -13.1% 2.5% 4.4% Sanofi India Ltd 8368 8.8% 6.9% 8.8% Dr. Lal PathLabs Ltd 3555 8.6% 58.2% 89.0% Sequent Scientific Ltd 294 -6.0% 40.1% 152.2% Eris Lifesciences Ltd 792 11.9% 30.9% 68.8% Shalby Ltd 194 7.4% 79.3% 163.2% FDC Ltd 372 5.4% 28.6% 29.2% Shilpa Medicare Ltd 632 17.2% 49.8% 25.0% Fermenta Biotech Ltd 313 -2.9% 5.6% 8.5% Solara Active Pharma Sciences Ltd 1645 -2.1% 10.7% 150.7% Fortis Healthcare Ltd 251 3.0% 55.1% 80.9% Strides Pharma Science Ltd 770 1.4% -5.4% 83.0% Gland Pharma Ltd 3948 15.5% 86.5% - SPARC Ltd 270 17.4% 51.2% 54.8% GSK Pharmaceuticals Ltd 1608 7.0% 9.8% 11.4% Sun Pharmaceutical Industries Ltd 774 14.6% 32.0% 51.8% Glenmark Pharmaceuticals Ltd 608 -6.9% 28.6% 37.6% Suven Life Sciences Ltd 82 -6.3% 16.5% 122.1% Granules India Ltd 379 14.1% 12.5% 36.4% Suven Pharmaceuticals Ltd 509 5.8% 10.2% -14.7% Gufic Biosciences Ltd 184 -2.0% 55.9% 103.5% Syngene International Ltd 639 9.7% 12.9% 35.4% HealthCare Global Enterprises Ltd 250 11.8% 65.0% 100.0% Take Solutions Ltd 63 0.4% 15.9% 55.5% Hester Biosciences Ltd 2365 -8.9% 40.7% 79.3% Thyrocare Technologies Ltd 1308 -0.4% 44.9% 91.6% Hikal Ltd 535 9.0% 213.0% 262.9% Torrent Pharmaceuticals Ltd 3070 5.8% 17.9% 26.0% Indoco Remedies Ltd 450 8.8% 49.7% 110.5% Unichem Laboratories Ltd 333 4.7% 15.1% 55.8% Indraprastha Medical Corp. Ltd 83 -1.8% 56.4% 37.0% Vimta Labs Ltd 324 22.1% 90.7% 232.3% IOL Chemicals and Pharma Ltd 664 9.3% -1.9% -11.7% Wockhardt Ltd 530 2.3% 10.2% 101.4% Source: BSE website; Source: BSE website; All prices are as on 30th July 2021 All prices are as on 30th July 2021 NIFTY PHARMA COMPANIES Price Mcap Change Company (Rs) (Rsmn) 1 M 6 M 12 M Aurobindo Pharma Ltd. 917 537218 -5.01% 1.2% 11.8% Biocon Ltd. 387 463860 -4.4% 3.9% -4.2% Cadila Healthcare Ltd. 586 599862 -9.2% 29.8% 60.3% Cipla Ltd. 920 742311 -5.3% 11.5% 34.2% Divi's Laboratories Ltd. 4905 1302030 11.3% 45.5% 91.5% Dr. Reddy's Laboratories Ltd. 4713 784005 -13.1% 2.5% 4.4% Alkem Laboratories Ltd. 3455 413043 8.1% 15.0% 35.7% Lupin Ltd. 1107 502538 -3.7% 9.86% 24.4% Torrent Pharmaceuticals Ltd. 3070 519463 5.8% 17.88% 26.0% Sun Pharmaceutical Industries Ltd. 774 1857085 14.6% 32.0% 51.8% Source: NSE website, Company Research; All prices are as on 30th July 2021 Nifty Pharma Index Vs. 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