MONTHLY DOSE

MARCH 2019

MONTHLY DOSE

AUGUST 2019

Sun Pharma announces regulatory filing of Tildrakizumab in Japan

DRL in collaboration with Exelixis to discover and develop novel therapies for cancer

Mylan and Biocon launch first Trastuzumab biosimilar, Ogivri'M

Zydus announces completion of Phase III trials of Saroglitazar Magnesium in type 2 diabetes mellitus

Lupin’s Aurangabad facility receives an EIR from the USFDA

Natco receives an EIR for its Kothur facility

France's ANSM completes inspection at Lupin's Mandideep facility (unit-1)

USFDA classifies the inspection of Cadila’s Moraiya unit as OAI

USFDA classifies Torrent Pharma’s inspection at Indrad facility as OAI

Indoco’s CRO – ANACIPHER clears USFDA inspection with zero 483

Sun Pharma announces licensing agreement with CSIR-IICT

Sun Pharma and China Medical System Holdings enter into licensing agreement for generic products in Mainland China

Glenmark receives approval for combination of Remogliflozin Etabonate and Metformin Hydrochloride for adults with type 2 diabetes in India

DRL announces the launch of Versavo in India and Vigabatrin Powder in the US market

Successful USFDA inspection at Alembic Pharmaceuticals bioequivalence facility at Vadodara with no observations

DRL gets 8 observations from USFDA for its Duvvada facility

Granules completed USFDA inspection with two minor observations

Lupin divests Kyowa Criticare to Neopharma group

Lupin launches Fluoxetine tablets, USP

Biocon's Malaysia Insulin Glargine manufacturing facility receives EUGMP Certification

Natco Pharma raises stake in OMRV Hospitals, invests in AACT Inc., USA

Alkem Laboratories received a Form 483 with 4 observations for US facility and no Form 483 for India facility

USFDA issued a Form 483 for Ipca Laboratories with 3 observations for its formulations manufacturing unit situated at Piparia

Lupin's subsidiary in South Africa announces commercial agreement with Creso Pharma for hemp oil based cannaQIX

Strides acquires USFDA approved manufacturing facility in the US

Granules India Limited to divest its stake in its JV located in India

Aurobindo Pharma signs deal to set up JV in China

Inspection of Unit-11 by EMA for Divi’s Laboratories with no critical observations

Alkem’s manufacturing facility at Daman received Form 483 with 2 observations

USFDA issues warning letter to Lantech Pharma for manufacturing violations at Andhra plant

To ensure authenticity, APIs of drugs may soon get track-and-trace codes

Indian Pharma firms receive 34% of FDA warnings this year

Drug regulator preparing list of dual-use APIs imported from unregistered firms

Price cap to take a toll on quality of premium hygiene products

China's new drug law may open door for Indian generic medicines: Report

Industry

Company

Global

News for the Month

Source: Media Reports and Company Press Releases

Company API Strengths Indications Brand (Company) Mkt Size

Granules India Amphetamine Sulfate Tablets

5/10mg Central nervous system stimulant Evekeo Tablets (Arbor Pharmaceuticals, LLC)

-

Unichem Chlorthalidone Tablets

25/50mg Indicated for management of hypertension either as the sole

therapeutic agent or to enhance the effect of other antihypertensive

drugs in the more severe forms of hypertension

Hygroton Tablets (Sanofi Aventis US)

USD122mn (Sep 2018)

Alembic Pharma

Dorzolamide Hydrochloride

Ophthalmic Solution

2% Carbonic anhydrase inhibitor indicated in the treatment of

elevated intraocular pressure in patients with ocular hypertension or

open-angle glaucoma

Trusopt Ophthalmic Solution (Merck)

USD35mn

Alembic Pharma

Fenofibrate Tablets 48/145mg Indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia

Tricor Tablets (AbbVie Inc.)

USD94mn

Lupin Hydrocortisone Valerate Cream

0.2% Relief of inflammatory and pruritic manifestation of corticosteroid

responsive dermatoses

Westcort Cream (Sun Pharma)

USD15mn

Cadila Healthcare

Ranolazine ER Tablets

500/1000mg Treat chronic angina Ranexa (Gilead Sciences, Inc.)

USD929mn (May 2019)

Glenmark Fulvestrant Injection 250mg/5mL (50mg/mL)

Treat breast cancer Faslodex Injection (AstraZeneca

Pharmaceuticals LP)

USD549.9mn

Unichem Solifenacin Succinate Tablets

5/10mg Indicated for the treatment of overactive bladder with symptoms

of urge urinary incontinence, urgency, and urinary frequency

Vesicare Tablets (Astellas Pharma Inc.)

USD967mn (Dec 2018)

Glenmark Pimecrolimus Cream 1% Used to treat skin conditions such as eczema (atopic dermatitis)

Elidel Cream (Bausch Health US, LLC.)

USD198.8mn

Final ANDA Approvals:

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 467 -1.9% -20.4% -15.9%

Abbott India Ltd 9140 7.8% 22.3% 9.5%

Ajanta Pharma Ltd 1021 15.9% 4.9% -19.7%

Alembic Ltd 36 -16.4% -12.5% -24.4%

Alembic Pharmaceuticals Ltd 498 -1.6% -10.2% -16.7%

Alkem Laboratories Ltd 1817 3.1% 4.0% -13.9%

Apollo Hospitals Enterprise Ltd 1509 13.2% 32.4% 27.3%

AstraZeneca Pharma India 1884 -5.2% -7.0% -0.1%

Aurobindo Pharma Ltd 601 8.9% -15.6% -15.7%

Biocon Ltd 235 0.4% -62.2% -62.3%

Bliss GVS Pharma Ltd 107 -29.1% -40.1% -44.2%

Cadila Healthcare Ltd 225 2.2% -29.4% -44.1%

Caplin Point Laboratories Ltd 425 5.8% 9.0% -2.7%

Cipla Ltd 473 -9.2% -14.8% -28.4%

Divi's Laboratories Ltd 1629 -1.8% -1.4% 24.8%

Dr Reddy's Laboratories Ltd 2555 -0.3% -3.1% 2.6%

Dr. Lal PathLabs Ltd 1247 15.2% 24.1% 19.6%

Eris Lifesciences Ltd 379 -5.1% -37.4% -48.2%

FDC Ltd 161 2.6% -2.7% -34.7%

Fortis Healthcare Ltd 125 0.6% -7.3% -15.0%

GSK Pharmaceuticals Ltd 1216 1.5% -8.4% -64.6%

Glenmark Pharmaceuticals Ltd 384 -8.3% -35.5% -42.3%

Granules India Ltd 91 0.2% -7.1% -21.5%

Gufic Biosciences Ltd 62 6.4% -11.6% -50.3%

HealthCare Global Enterprises Ltd 104 3.1% -47.4% -59.9%

Hester Biosciences Ltd 1628 -2.5% 26.3% 29.6%

Hikal Ltd 145 -3.6% -10.0% -10.0%

Indoco Remedies Ltd 145 -7.4% -18.0% -35.4%

Indraprastha Medical Corp. Ltd 36 -1.9% -1.9% -26.7%

IOL Chemicals and Pharma Ltd 178 -7.8% -2.6% 44.2%

IPCA Laboratories Ltd 963 0.4% 18.7% 25.0%

J.B. Chemicals & Pharma Ltd 382 3.5% 17.2% 12.4%

Jubilant Life Sciences Ltd 439 -1.2% -44.1% -39.3%

Kopran Ltd 28 -10.4% -23.9% -47.8%

BSE Health Care Index Price Performance

Companies

Price

Chg (%)

1 M 6 M 12 M

Laurus Labs Ltd 328 -3.7% -1.2% -25.1%

Lincoln Pharmaceuticals Ltd 143 0.0% -13.2% -44.8%

Lupin Ltd 740 -1.6% -3.2% -20.6%

Mangalam Drugs and Organics Ltd 31 -13.4% -32.2% -62.9%

Marksans Pharma Ltd 14 1.9% -41.1% -63.9%

Medicamen Biotech Ltd 343 -14.2% -15.4% -36.0%

Merck Ltd 4120 -12.1% 31.4% 17.2%

Morepen Laboratories Ltd 16 -1.6% -6.6% -47.1%

Narayana Hrudayalaya Ltd 235 5.6% 14.0% -6.0%

Natco Pharma Ltd 541 3.7% -5.9% -30.6%

Nectar Lifesciences Ltd 13 -4.4% -23.5% -54.4%

Neuland Laboratories Ltd 461 -6.5% -39.7% -40.7%

Novartis India Ltd 568 -11.7% -18.1% -39.9%

Opto Circuits India Ltd 3 2.2% -57.0% -73.4%

Panacea Biotec Ltd 131 7.2% -34.7% -46.8%

Pfizer Ltd (India) 2921 -7.3% -9.6% -19.2%

Piramal Enterprises Ltd 2032 13.7% -12.7% -36.5%

Poly Medicure Ltd 190 8.5% -7.8% -10.9%

RPG Life Sciences Ltd 255 23.3% 12.8% -12.5%

Sanofi India Ltd 6104 1.4% 2.1% -4.7%

Shalby Ltd 80 -10.0% -40.7% -49.3%

Shilpa Medicare Ltd 214 -39.8% -39.0% -57.2%

SMS Pharmaceuticals Ltd 60 22.5% -8.5% -21.5%

Strides Shasun Ltd 381 2.6% -9.3% -23.1%

SPARC Ltd 160 4.7% -10.3% -60.2%

Sun Pharmaceutical Industries Ltd 451 9.8% 1.2% -30.9%

Suven Life Sciences Ltd 260 16.7% 7.8% -7.0%

Syngene International Ltd 309 1.3% -47.7% -48.1%

Thyrocare Technologies Ltd 465 11.7% -11.0% -28.5%

Torrent Pharmaceuticals Ltd 1708 3.3% -5.4% -5.8%

Unichem Laboratories Ltd 173 6.1% -10.2% -24.7%

Vimta Labs Ltd 96 -7.3% -46.3% -66.5%

Vivimed Labs Ltd 15 4.5% -30.4% -76.8%

Wockhardt Ltd 245 -22.2% -38.2% -63.1%

Source: BSE website; All prices are as on 30th August 2019

Source: BSE website; All prices are as on 30th August 2019

NIFTY PHARMA COMPANIES

Company

Price (Rs)

Mcap (Rsmn)

Chg (%)

1 M 6 M 12 M

Aurobindo Pharma Ltd. 601 351960 8.85% -15.6% -15.7%

Biocon Ltd. 235 282300 0.4% -62.2% -62.3%

Cadila Healthcare Ltd. 225 230496 2.2% -29.4% -44.1%

Cipla Ltd. 473 380513 -9.2% -14.8% -28.4%

Divi's Laboratories Ltd. 1629 432422 -1.8% -1.4% 24.8%

Dr. Reddy's Laboratories Ltd. 2555 363733 -0.3% -3.1% 2.6%

Glenmark Pharmaceuticals Ltd. 384 108324 -8.3% -35.5% -42.3%

Lupin Ltd. 740 335030 -1.6% -3.2% -20.6%

Piramal Enterprises Ltd. 2032 404016 13.7% -12.7% -36.5%

Sun Pharmaceutical Industries Ltd. 451 1081260 9.8% 1.2% -30.9%

Source: NSE website, Company Research; All prices are as on 30th August 2019

Nifty Pharma Index Vs. Nifty Index

Source: NSE website

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