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MONTHLY DOSE
MARCH 2019
MONTHLY DOSE
APRIL 2020
Biocon's insulin manufacturing facility in Malaysia gets EIR with VAI
classification from USFDA
Cipla announces successful completion of Phase-3 clinical study for generic
version of GSK’s Advair Diskus
Aurobindo Pharma calls off USD1bn deal with Sandoz after failing to get FTC
nod
Lupin’s Aurangabad facility gets an EIR form USFDA
Lupin launches Mycophenolic Acid DR Tablets USP
Granules Vizag facility gets EU GMP approval
Lupin’s Nagpur facility receives EIR from USFDA
USFDA requested all manufacturers of SMS Pharmaceuticals to withdraw
Ranitidine products from the US market
DRL’s API manufacturing plant 5 at Miryalaguda, Telangana received an EIR
from the USFDA
Hydroxychloroquine production scaled up for Zydus Cadila
Dr. Reddy announces the launch of an authorized generic version of NitroDur
(nitroglycerin) Transdermal Infusion System in the US market
Dr. Reddy announces the launch of Amphetamine sulfate tablets in the US
market
Biocon and Mylan Launch Fulphila, Biosimilar Pegfilgrastim, in Australia
Lupin’s Mandideep Unit II facility receives an EIR from USFDA
Biocon Biologics receives EIR from USFDA for 2 facilities
Shilpa Medicare receives EIR from USFDA for Raichur API Unit
Wockhardt receives QIDP status for antibiotic WCK 6777 from USFDA
Aurobindo’s formulation facility Unit IV classified as VAI by USFDA
Shilpa Medicare launches an anticancer drug DASASHIL
Natco Pharma gets EIR for Kothur formulation facility
Gufic Lifesciences gets ANVISA, Brazil approval for its Injectable plant
Lincoln Pharma received approval to manufacture Hydroxychloroquine and
Hydroxychloroquine Sulphate Tablets
DRL announces the launch of Fenofibrate Tablets USP, in the US market
Natco's Vizag formulation facility receives final approval for its sANDA
product from the USFDA
Biocon and Mylan launch Fulphila biosimilar Pegfilgrastim in Canada
Strides develops and commences export of Favipiravir Antiviral Tablets
Hester Biosciences collaborates with IIT Guwahati for Covid-19 vaccine
Fire mishap at Suven Lifesciences unit in Hyderabad Glenmark received approval from DCGI to conduct clinical trials in India on
Favipiravir Antiviral tablets for Covid-19 patients
Lupin’s Pithampur Unit-1 facility received an EIR from USFDA
Morepen Laboratories gets ISO-13485 certification for its medical devices
manufacturing facility at Baddi
IPCA seeks clarification from USFDA on Hydroxychloroquine risk
Govt frees exports of all APIs, formulations except paracetamol
AIIMS issues guidelines on reuse of PPE, citing depletion of stocks
ICMR releases plasma trials protocol, seeks registrations
Pharmacists to ration drugs to avoid shortage
WHO prematurely publishes remdesivir results
Novartis announces plan to initiate clinical trial of canakinumab for patients with
Covid-19 pneumonia
Industry
Company
Global
News for the Month
Source: Media Reports and Company Press Releases
Company API Strengths Indications Brand (Company) Mkt Size
Cadila Lamotrigine ER
Tablets
25/50/100/200/
250/300mg
Indicated for the treatment of certain
types of seizures
Lamictal XR
(GlaxoSmithKline)
-
Cadila Perphenazine Tablets 2/4/8/16mg Indicated for the treatment of schizophrenia and for the control of
severe nausea and vomiting in
adults
Trilafon (Apicore) -
Cipla Albuterol Sulfate
Inhalation Aerosol
90mcg (base)/
actuation
Used for treatment of acute episodes of bronchospasm or prevention of
asthmatic symptoms
Proventil HFA Inhalation Aerosol (Merck Sharp &
Dohme Corps)
USD153mn
Granules Butalbital, Acetaminophen and
Caffeine Capsules
50/300/40mg Used for the relief of the symptom complex of tension (or muscle
contraction) headache
Butalbital, Acetaminophen and
Caffeine Capsules
(Nexgen Pharma, Inc.)
USD42mn
Cadila Imatinib Mesylate
Tablets
100/400mg Used to treat certain types of leukemia (blood cancer), bone
marrow disorders, skin cancer and
tumors of the stomach and digestive
system
Gleevec (Novartis
Pharmaceuticals)
USD868mn
(July 2018)
Cadila Baclofen Tablets 5mg Used to treat muscle spasms caused by certain conditions such as
multiple sclerosis, spinal cord
injury/disease
Ozobax (Metacel
Pharmaceuticals')
-
Cadila Erlotinib Tablets 25/100/150mg Used to treat non-small cell lung cancer or pancreatic cancer that has
spread to other parts of the body
(metastatic)
Tarceva Tablets
(Genentech Inc.)
USD212mn (Annual sales
March 2019)
Aurobindo Fluoxetine Tablets 10/20mg Indicated for the acute and
maintenance treatment of major
depressive disorder in adult patients
and in pediatric patients aged 8 to
18 years
Prozac (Eli Lilly) USD42mn
JB Chemicals Carbamazepine ER
Tablets
100/200/400mg Indicated for treatment of Epilepsy
and Trigeminal Neuralgia
Tegretol XR Tablet (Novartis Pharmaceuticals
Corp.)
USD128mn
Granules Vigabatrin for Oral
Solution
500mg Indicated as adjunctive therapy Sabril (Lundbeck
Pharmaceuticals)
USD225mn
Final ANDA Approvals:
Source: Media Reports and Company Press Releases
Company API Strengths Indications Brand (Company) Mkt Size
Cadila Empagliflozin
Tablets
10/25mg Used together with diet and exercise to improve blood sugar
control in adults with Type 2
diabetes mellitus
Jardiance
(Boehringer Ingelheim)
USD3.4bn
(Sept 2019)
Cadila Macitentan
Tablets
10mg Indicated for the treatment of
pulmonary arterial hypertension
Opsumit Tablets (Actelion) -
Alembic Alcaftadine Ophthalmic
Solution
0.25% Indicated for the prevention of itching associated with allergic
conjunctivitis
Lastacaft Ophthalmic
Solution (Allergan Inc.)
USD7mn
Glenmark Dapagliflozin and Saxagliptin
Tablets
10/5mg Used to improve blood sugar control in adults with type 2
diabetes mellitus
Qtern (AstraZeneca AB) USD10.4mn
Lupin Arformoterol Tartrate
Inhalation
Solution
15mcg (base)/2mL
Unit dose vials
Indicated for long term maintenance treatment of bronchoconstriction in
patients with chronic obstructive
pulmonary disease
Brovana (Sunovion
Pharmaceuticals Inc.)
USD489mn
Tentative ANDA Approvals:
Source: Media Reports and Company Press Releases
Company API Strengths Indications Brand (Company) Mkt Size
Strides Flucytosine Capsules 250/500mg Indicated only in the treatment of serious infections caused by
susceptible strains of Candida and/
or Cryptococcus
Ancobon Capsules
(Bausch Health US, LLC.)
USD45mn
Granules Trospium Chloride
ER Capsules
60mg Muscarinic Antagonist indicated for
the treatment of overactive bladder
Sanctura XR Capsules
(Allergan, Inc)
USD25mn
Caplin Point Ropivacaine Hydrochloride
Injection
0.2 % in 40mg/20mL
(2mg/mL), 0.5 %
in 100mg/20mL (5mg/mL), 0.5 %
in 150mg/30mL
(5mg/mL) and 1 % in
200mg/20mL
(10mg/mL)
Single-dose vial
A long acting local anesthetic drug used for surgery or acute pain
management
NAROPIN Injection (Fresenius Kabi USA
LLC.)
USD34mn
Final ANDA Approvals:
Source: Media Reports and Company Press Releases
BSE Health Care Index Price Performance
Companies
Price
Change
1 M 6 M 12 M
Aarti Drugs Ltd 715 41.4% 32.7% 14.7%
Abbott India Ltd 17668 14.3% 48.4% 137.6%
Ajanta Pharma Ltd 1486 8.7% 45.0% 50.1%
Alembic Ltd 50 41.0% 0.00% 20.0%
Alembic Pharmaceuticals Ltd 746 39.8% 36.5% 34.1%
Alkem Laboratories Ltd 2608 12.0% 32.0% 51.7%
Apollo Hospitals Enterprise Ltd 1394 22.5% -4.6% 14.7%
AstraZeneca Pharma India 3032 26.8% 11.9% 28.4%
Aurobindo Pharma Ltd 626 51.5% 35.2% -23.5%
Biocon Ltd 354 30.8% 42.5% -40.3%
Bliss GVS Pharma Ltd 98 -2.5% -27.3% -41.8%
Cadila Healthcare Ltd 324 21.3% 29.6% -0.3%
Caplin Point Laboratories Ltd 351 24.3% -11.2% -3.5%
Cipla Ltd 590 39.4% 27.0% 4.5%
Divi's Laboratories Ltd 2333 17.4% 34.3% 33.8%
Dr. Reddy's Laboratories Ltd 3937 26.3% 42.6% 34.2%
Dr. Lal PathLabs Ltd 1587 13.2% 0.3% 52.7%
Eris Lifesciences Ltd 501 36.1% 13.1% -20.5%
FDC Ltd 245 24.9% 35.5% 42.2%
Fortis Healthcare Ltd 127 0.9% -8.6% -8.0%
GSK Pharmaceuticals Ltd 1445 16.0% -10.0% 12.7%
Glenmark Pharmaceuticals Ltd 337 63.6% 8.9% -47.1%
Granules India Ltd 163 13.2% 25.7% 45.1%
Gufic Biosciences Ltd 66 40.8% -6.9% -16.4%
HealthCare Global Enterprises Ltd 71 -5.9% -39.3% -65.6%
Hester Biosciences Ltd 1337 44.5% -19.6% -6.8%
Hikal Ltd 112 60.4% -5.7% -36.6%
Indoco Remedies Ltd 232 10.7% 45.2% 15.6%
Indraprastha Medical Corp. Ltd 39 15.9% 2.6% 2.7%
IOL Chemicals and Pharma Ltd 289 64.2% 56.4% 61.3%
IPCA Laboratories Ltd 1619 16.6% 65.9% 69.8%
J.B. Chemicals & Pharma Ltd 557 9.6% 68.2% 62.0%
Jubilant Life Sciences Ltd 400 60.9% -24.4% -39.3%
Kopran Ltd 28 10.1% 1.8% -26.9%
BSE Health Care Index Price Performance
Companies
Price
Change
1 M 6 M 12 M
Laurus Labs Ltd 512 58.8% 40.7% 34.1%
Lincoln Pharmaceuticals Ltd 156 16.6% -3.1% -13.8%
Lupin Ltd 835 41.6% 14.4% -4.1%
Mangalam Drugs and Organics Ltd 72 138.2% 121.1% 38.1%
Marksans Pharma Ltd 20 43.7% 36.5% -15.3%
Medicamen Biotech Ltd 261 44.4% -23.4% -49.2%
Merck Ltd 4322 18.6% -9.2% 16.3%
Morepen Laboratories Ltd 18 92.0% 11.7% 10.0%
Narayana Hrudayalaya Ltd 279 12.9% 1.9% 38.2%
Natco Pharma Ltd 611 20.7% 2.9% 12.3%
Nectar Lifesciences Ltd 14 43.6% 9.1% -13.1%
Neuland Laboratories Ltd 452 59.5% -8.9% -35.8%
Novartis India Ltd 626 24.6% -9.7% -9.5%
Opto Circuits India Ltd 4 126.0% -8.8% -48.8%
Panacea Biotec Ltd 172 57.5% 23.4% -10.6%
Pfizer Ltd (India) 4905 21.9% 25.8% 56.8%
Piramal Enterprises Ltd 989 5.3% -41.7% -58.0%
Poly Medicure Ltd 228 -3.3% 11.1% 16.8%
RPG Life Sciences Ltd 246 44.1% 15.7% 4.4%
Sanofi India Ltd 7776 24.6% 17.4% 38.0%
Shalby Ltd 70 51.6% -32.5% -46.6%
Shilpa Medicare Ltd 363 48.3% 32.7% -7.1%
SMS Pharmaceuticals Ltd 43 62.9% 5.5% -28.3%
Strides Shasun Ltd 444 37.5% 13.7% -7.6%
SPARC Ltd 132 36.4% -6.9% -21.9%
Sun Pharmaceutical Industries Ltd 465 32.0% 8.1% 1.7%
Suven Life Sciences Ltd 46 114.7% -83.9% -82.6%
Syngene International Ltd 321 33.1% -2.8% -47.3%
Thyrocare Technologies Ltd 509 2.7% -7.5% 3.8%
Torrent Pharmaceuticals Ltd 2345 18.9% 32.8% 30.8%
Unichem Laboratories Ltd 148 -2.3% -22.1% -22.7%
Vimta Labs Ltd 80 35.3% -32.1% -57.4%
Vivimed Labs Ltd 12 71.2% -15.4% -47.1%
Wockhardt Ltd 256 48.2% -7.0% -38.0%
Source: BSE website; All prices are as on 30th April 2020
Source: BSE website; All prices are as on 30th April 2020
NIFTY PHARMA COMPANIES
Company
Price
(Rs)
Mcap
(Rsmn)
Change
1 M 6 M 12 M
Aurobindo Pharma Ltd. 626 366768 51.54% 35.2% -23.5%
Biocon Ltd. 354 424740 30.8% 42.5% -40.3%
Cadila Healthcare Ltd. 324 331641 21.3% 29.6% -0.3%
Cipla Ltd. 590 474920 39.4% 27.0% 4.5%
Divi's Laboratories Ltd. 2333 619298 17.4% 34.3% 33.8%
Dr. Reddy's Laboratories Ltd. 3937 560623 26.3% 42.6% 34.2%
Glenmark Pharmaceuticals Ltd. 337 95147 63.6% 8.9% -47.1%
Lupin Ltd. 835 378222 41.6% 14.44% -4.1%
Piramal Enterprises Ltd. 989 196932 5.3% -41.7% -58.0%
Sun Pharmaceutical Industries Ltd. 465 1115331 32.0% 8.1% 1.7%
Source: NSE website, Company Research; All prices are as on 30th April 2020
Nifty Pharma Index Vs. Nifty Index
Source: NSE website
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