MONTHLY DOSE MARCH 2019
MONTHLY DOSE
MARCH 2019
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Aurobindo Pharma acquires 7 oncology products from US-based firm
Cipla launches generic cinacalcet hydrochloride tablets in US
SEBI asks Sun Pharma to explain alleged fund diversion of Rs42,000cr
Abbott fined Rs96lakh for profiteering from GST
Biocon gets 6 observations from USFDA after inspection of its Bengaluru plant
Alembic Pharma shutdown operation at Samardung South Sikkim
Suven announces the asset purchase agreement of Rising Pharmaceuticals
through its joint venture partner, Shore Suven Pharma Inc.
USFDA issues warning letter to Jubilant Life for Roorkee facility
Cipla arm completes acquisition of stake in Wellthy Therapeutics
USFDA concludes inspection of Unichem Lab's Ghaziabad facility
Dr. Reddy’s wants Indivior to pay USD70mn for Opioid delay
Biocon biosimilar plant criticized again by the FDA
Pfizer’s oncology biosimilar Trazimera receives USFDA approval to treat HER2
overexpressing breast cancer
Piramal Ent launches generic version of Amgen's top selling Sensipar in US
HitGen and SPARC enter innovative drug discovery research collaboration
Sun Pharma hikes stake in Russia's PJSC Biosintez to 96.96%
Aurobindo received EIR for Unit-4 facility
US drug regulator flags concerns over Lupin's Mandideep Unit-1, blocks new
approvals
USFDA classifies Lupin's Somerset facility as 'Official Action Indicated'
Jubilant Cadista Pharmaceuticals recalls over 5,700 bottles of anti-depressant
drug from US
Lupin launches Fluocinonide Ointment USP in the US
Suven Life Sciences secures product patents in Eurasia, Europe, South Korea
and Sri Lanka
Strides receives USFDA approval for greenfield oral dosage facility in singapore
USFDA Inspection completed at Alidac Pharmaceuticals, subsidiary of Cadila
Dr. Reddy's Laboratories said it has launched Tadalafil Tablets
Lupin's Pune Biotech facility receives EU GMP clearance
Strides Pharma’s board approves divestment of Australia business
Lupin launches generic Levothyroxine Sodium Tablets USP
USFDA asks Alkem to withhold manufacturing of a product at St Louis facility
Glenmark Pharma gets 5 observations from USFDA for Goa plant
Dr. Reddy’s Hyderabad Unit receives no observation under form 483
Sun Pharma receives 483 for Baska facility, co says responded to USFDA
Lupin & YI Biologics receive PMDA approval for Etanercept in Japan
Wockhardt in talks with private equity cos to raise USD300mn
Cadila’s arm receives 1 observation from USFDA for Ahmedabad plant
For Cipla, USFDA issued 8 GMP observations and 10 observations pertaining to
the PAI for a novel technology product slated for approval beyond 2024 while
inspecting Kurkumbh plant
Government plans to colour code generic drugs
Price hikes continue to drive Pharma sales in India
Ayushman Bharat on way to become world's largest free healthcare scheme
Indian Pharma Market grew by 10% in February to Rs10,762cr
FDA approves generic valsartan amid drug shortage
Baring set to acquire health tech co AGS in Rs2,230cr deal
USFDA accepts Allergan's NDA for ubrogepant for acute treatment of migraine
Industry
Company
Global
News for the Month
Source: Media Reports and Company Press Releases
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Company API Strengths Indications Brand (Company) Mkt Size
Laurus labs Abacavir, Dolutegravir, &
Lamivudine tabs
600mg/50mg/
30mg
Treating HIV Triumeq (ViiV Healthcare) -
Cadila
Healthcare
Sitagliptin & Metformin
Hydrochloride
ER tabs
50mg/500mg, 50mg/1,000mg
&100mg/1,000mg
Management of type 2 diabetes Janumet XR (Merck) -
Company API Strengths Indications Brand (Company) Mkt Size
Wockhardt Abiraterone acetate 250mg Treat Prostate Cancer Zytiga (J&J) USD1.26bn
Glenmark
Pharma
Telmisartan & Hydrochlorothiazide
tabs
40mg/12.5mg, 80mg/12.5mg &
80mg/25mg
Treat hypertension Micardis HCT tabs
(Boehringer Ingelheim)
USD40.6mn
Cadila Rivastigmine
Transdermal System
4.6mg/ 9.5mg/
13.3mg/24hrs
Treatment of dementia Exelon patch (Mylan) USD214mn
Cadila Rosuvastatin tabs 5/10/20/40mg Reduce cholesterol by the liver Crestor (Astrazeneca) -
Lupin Imatinib Mesylate 100/400mg Treat certain types of cancer Gleevec (Novartis) USD655mn
Alembic Pharma Clobetasol
Propionate Ointment
0.05% Treat various skin disorders Temovate Ointment
(Glaxo Wellcome Inc.)
USD63mn
Lupin Atorvastatin
Calcium tabs
10/20/40/80mg Lowering cholesterol Lipitor (Pfizer) USD696mn
Laurus labs Hydroxychloroquine 200mg Treatment of malaria Plaquenil (Concordia ) USD215.3mn
Cadila Atenolol &
Chlorthalidone tabs
50mg/25mg &
100mg/25mg
Treat high blood pressure Tenoretic (Astrazeneca) -
Cadila Potassium Chloride
ER capsules
8mEq (600mg) &
10mEq(750mg)
Mineral supplement to treat/prevent
low amounts of potassium in blood
Potassium Chloride ER
Capsules (Actavis Labs)
USD75.4mn
(June 2016)
Unichem Allopurinol tabs 100/300mg Treatment for leukemia, lymphoma
and malignancies for cancer therapy
Zyloprim (Casper
Pharma)
-
Glenmark
Pharma
Clindamycin &
Benzoyl Peroxide Gel
1%|5% Topical treatment of acne vulgaris BenzaClin Gel (Valeant) USD99.4mn
Cadila Valsartan and Hydrochlorothiazide
tabs
80mg/12.5mg, 160mg/12.5mg,
160mg/25mg,
320mg/12.5mg, &
320mg/25mg
Treat high blood pressure Diovan HCT -
Cadila Acyclovir Ointment 5% Antiviral drug Zovirax (GSK) USD92mn
Alembic Pharma Azelastine Hydrochloride
Ophthalmic Solution
0.05% Treat allergic conjunctivitis Optivar Ophthalmic
Solution (Mylan)
USD8.5mn
Cadila Lurasidone
Hydrochloride tabs
20/40/60/80/120
mg
Treat mental disorders Latuda (Sunovion
Pharmaceuticals)
USD3217mn
Caplin Point labs Glycopyrrolate
injection
0.2mg/ml (in
1/2/5/20ml vial
Glycopyrrolate is an anticholinergic
drug
Robinul (West-Ward
Pharmaceuticals)
USD110mn
Lupin Sildenafil tabs 25/50/100mg Erectile dysfunction Viagra (Pfizer) USD611mn
Cadila, Lupin,
Unichem
Tadalafil tabs 2.5/5/10/20mg Erectile Dysfunction Cialis (Eli Lilly) USD1780mn
Cadila Ambrisentan tabs 5/10mg Treat high blood pressure Letairis (Gilead Sciences) USD943mn
Tentative ANDA Approvals:
Final ANDA Approvals:
Source: Media Reports and Company Press Releases
Source: Media Reports and Company Press Releases
BSE Health Care Index Price Performance
Companies
Price
Chg (%)
1 M 6 M 12 M
Aarti Drugs Ltd 640 8.1% 17.2% 26.4%
Abbott India Ltd 7297 -9.4% -6.2% 33.9%
Ajanta Pharma Ltd 1030 0.6% -2.9% -26.7%
Alembic Ltd 42 3.8% 0.2% -20.7%
Alembic Pharmaceuticals Ltd 531 -10.8% -15.1% -3.5%
Alkem Laboratories Ltd 1752 -7.2% -14.5% -11.4%
Apollo Hospitals Enterprise Ltd 1221 -7.8% 17.1% 14.9%
AstraZeneca Pharma India 1998 24.5% 26.9% 115.7%
Aurobindo Pharma Ltd 786 0.0% 5.7% 41.0%
Biocon Ltd 611 -5.8% -11.6% 2.8%
Bliss GVS Pharma Ltd 180 15.0% 1.8% -7.9%
Cadila Healthcare Ltd 347 8.6% -10.3% -8.5%
Caplin Point Laboratories Ltd 402 10.7% -2.4% -29.8%
Cipla Ltd 529 2.5% -19.0% -2.6%
Divi's Laboratories Ltd 1703 13.2% 30.1% 56.3%
Dr Reddy's Laboratories Ltd 2774 1.9% 9.6% 33.2%
Dr. Lal PathLabs Ltd 1055 -2.1% 10.4% 20.5%
Eris Lifesciences Ltd 644 3.2% -10.9% -19.0%
FDC Ltd 168 1.9% -21.8% -33.5%
Fortis Healthcare Ltd 136 0.6% 0.6% 10.0%
GSK Pharmaceuticals Ltd 1300 -7.8% -10.0% -37.7%
Glenmark Pharmaceuticals Ltd 646 -0.9% 2.1% 22.5%
Granules India Ltd 114 25.5% 20.1% 10.4%
Gufic Biosciences Ltd 76 -9.4% -33.8% -29.7%
HealthCare Global Enterprises Ltd 215 9.7% -0.3% -26.5%
Hester Biosciences Ltd 1545 25.7% 43.8% -3.7%
Hikal Ltd 175 14.6% 9.2% -14.8%
Indoco Remedies Ltd 203 9.6% 4.9% -3.8%
Indraprastha Medical Corp. Ltd 38 -1.9% -3.4% -20.6%
IOL Chemicals and Pharma Ltd 190 -5.9% 57.8% 139.4%
IPCA Laboratories Ltd 983 27.2% 45.9% 50.0%
J.B. Chemicals & Pharma Ltd 360 15.1% 22.9% 16.3%
Jubilant Life Sciences Ltd 664 -5.6% -9.2% -20.9%
Kopran Ltd 42 -4.6% 4.4% -24.6%
BSE Health Care Index Price Performance
Companies
Price
Chg (%)
1 M 6 M 12 M
Laurus Labs Ltd 400 8.1% -7.1% -20.5%
Lincoln Pharmaceuticals Ltd 213 12.3% -9.8% 1.1%
Lupin Ltd 739 -16.0% -17.9% 0.4%
Mangalam Drugs and Organics Ltd 55 -15.7% -23.7% -66.0%
Marksans Pharma Ltd 25 -2.9% -15.5% -21.5%
Medicamen Biotech Ltd 485 17.6% 5.0% -18.6%
Merck Ltd 3674 11.4% 42.5% 144.2%
Morepen Laboratories Ltd 17 -13.5% -25.3% -44.1%
Narayana Hrudayalaya Ltd 214 13.3% -12.4% -23.3%
Natco Pharma Ltd 572 -17.3% -23.5% -24.2%
Nectar Lifesciences Ltd 17 -6.3% -23.8% -35.3%
Neuland Laboratories Ltd 674 27.5% 0.1% -4.6%
Novartis India Ltd 686 -5.4% -8.2% 12.0%
Opto Circuits India Ltd 8 -3.4% -10.2% 4.7%
Panacea Biotec Ltd 198 32.0% 15.1% -25.8%
Pfizer Ltd (India) 3321 9.8% 11.5% 51.9%
Piramal Enterprises Ltd 2755 35.6% 19.6% 12.9%
Poly Medicure Ltd 217 -1.2% 0.9% -13.2%
RPG Life Sciences Ltd 248 15.1% 4.1% -35.2%
Sanofi India Ltd 5835 -9.7% -7.3% 13.0%
Shalby Ltd 129 -3.5% -4.6% -
Shilpa Medicare Ltd 340 -10.5% -16.2% -26.8%
SMS Pharmaceuticals Ltd 62 -7.4% -0.6% -15.5%
Strides Shasun Ltd 472 2.3% 8.7% -29.8%
SPARC Ltd 192 22.0% -44.0% -49.3%
Sun Pharmaceutical Industries Ltd 479 12.6% -23.1% -3.3%
Suven Life Sciences Ltd 261 35.3% -3.4% 55.5%
Syngene International Ltd 588 1.4% -1.4% -0.1%
Thyrocare Technologies Ltd 531 -2.9% -17.7% -11.8%
Torrent Pharmaceuticals Ltd 1952 7.4% 18.3% 56.4%
Unichem Laboratories Ltd 195 -4.3% -0.6% -32.0%
Vimta Labs Ltd 200 -24.1% -24.7% 13.9%
Vivimed Labs Ltd 23 -6.8% -51.1% -67.1%
Wockhardt Ltd 443 0.4% -18.2% -39.0%
Source: BSE website; All prices are as on 29th March 2019
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Source: BSE website; All prices are as on 29th March 2019
NIFTY PHARMA COMPANIES
Company
Price
(Rs)
Mcap
(Rsmn)
Chg (%)
1 M 6 M 12 M
Aurobindo Pharma Ltd 786 460523 -0.04% 5.7% 41.0%
Biocon Ltd 611 366600 -5.8% -11.6% 2.8%
Cadila Healthcare Ltd 347 354829 8.6% -10.3% -8.5%
Cipla Ltd 529 426150 2.5% -19.0% -2.6%
Divi's Laboratories Ltd 1703 452146 13.2% 30.1% 56.3%
Dr. Reddy's Laboratories Ltd 2774 460262 1.9% 9.6% 33.2%
Glenmark Pharmaceuticals Ltd 646 182154 -0.9% 2.1% 22.5%
Lupin Ltd 739 334134 -16.0% -17.9% 0.4%
Piramal Enterprises Ltd 2755 496600 35.6% 19.6% 12.9%
Sun Pharmaceutical Industries Ltd 479 1149876 12.6% -23.1% -3.3%
Source: NSE website, Company Research; All prices are as on 29th March 2019
Nifty Pharma Index Vs. Nifty Index
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