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Lupin Ltd — Investor Presentation 2020
May 29, 2020
61031_rns_2020-05-29_05d32223-3ef1-4811-95ee-aef0f3118a3d.pdf
Investor Presentation
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May 29, 2020
BSE Limited
Department of Corporate Services, P. J. Towers, Dalal Street, MUMBAI - 400 001.
National Stock Exchange of India Limited
Exchange Plaza, Bandra Kurla Complex, Bandra (East), Mumbai - 400 051.
Dear Sirs,
Sub: Q4 FY20 Investor Presentation.
Pursuant to Regulation 30(2) read with Schedule III Part A (15) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, enclosed is a copy of the Q4 FY2020 Investor Presentation.
Kindly confirm receipt.
Thanking you,
Yours faithfully,
For LUPIN LIMITED
RAJVARDH
Digitally signed by RAJVARDHAN VISHNU SATAM DN: c=IN, o=Personal, postalCode=400062, st=Maharashtra, 2.5.4.20=c19d8ef961d9fa59e973a093a4d3924 b2532eb2f496ea7e2abcf74700f5375b7, serialNumber=df8ebe60a88c796663c738ea25 bfa0b475d195f726cdb67a2ff09c4242771b2a, cn=RAJVARDHAN VISHNU SATAM Date: 2020.05.29 21:03:47 +05'30'
AN VISHNU
SATAM
R. V. SATAM COMPANY SECRETARY
Encl.: a/a
Registered Office: 3[rd] Floor, Kalpataru Inspire, Off W. E. Highway, Santacruz (East), Mumbai - 400 055 India. Tel: (91-22) 6640 2323. Corporate Identity Number: L24100MH1983PLC029442 www.lupin.com
www.lupin.com
Investor Presentation Q4 FY2020
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May 29, 2020
Safe Harbor Statement
Materials and information provided during this presentation may contain ‘forward-looking statements’. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements.
Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions such as interest rate and fluctuations. Risks and uncertainties with currency exchange particularly apply respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, technological advances and patents obtained by competitors. Challenges inherent in new product development, including completion of clinical trials; claims and concerns about product safety and efficacy; obtaining regulatory approvals; domestic and foreign healthcare reforms; trends toward managed care and healthcare cost containment; and governmental laws and regulations affecting domestic and foreign operations.
Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials, and failure to gain market acceptance.
You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation.
The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise.
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PG 2
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Covid-19 Update
Covid-19: Our Res onse p
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Employee Safety
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Travel restrictions enacted early to contain the spread
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Field and Office Staff rapidly converted to remote work (home) during local lockdowns
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Social Distancing and PPE SOPs applied to manufacturing and R&D environments
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Provision of essential PPE, sanitizers, safety and health information to all employees
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Increased workplace sanitizations
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Business Continuity
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R&D and Manufacturing facilities remained operational after establishing thorough SOPs
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Agile supply chain acted early to ensure continued supply of materials to / from our facilities
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Robust Leadership engagement across functions and regions
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Engaged customers early to fulfill stocking needs and shifts to 90 day refills in the U.S.
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Ramped up production of Covid19 usage medicines
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Commercial Strategy
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Lockdown Phase
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✓ Digital engagement with HCP’s, suppliers
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Post Lockdown Phase
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✓ Fieldwork resumed on a
country by country, territory by territory basis within guidelines and proper PPE
- ✓ Each business has prepared localized plans for resumption of work to ensure the safety of Lupin employees
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Employee Support
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Employee engagement through interactive leadership webinar series and online training for up skilling
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Enhanced communication from CEO & MD in global messages
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Medical & Life insurance covers doubled for India employees
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Helpline & SOS care for employees
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PG 4
“New Normal” Pla book - Safe uardin Health & Safet y g g y
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Clear SOPs on safety at all workplaces
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PG 5
“New Normal” Pla book - Safe uardin Health & Safet y g g y
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Field employees (India) mandated to attain Red Cross certification on Covid19 knowledge and prevention measures
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Covid-19: Su ortin Communities pp g
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Launched a consolidated & very high Impact CSR program; Proactive coordination with Government agencies
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Su orted Set u pp p Lupin COVID-19 Crisis Response Fund Dedicated fund to support communities
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Su ortin Communities - #HeroesOfLu in pp g p
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PG 8
Lu in – Awards and Accolades p
- McKesson Supplier of the Year Award - 2019
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Walmart Supplier of the Year Award - 2018
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Cardinal Supply Chain Excellence Award – 2018
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India Pharma Innovation of the Year 2019 - Department of Pharmaceuticals, Govt. of India
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Operational Excellence in Manufacturing – India Pharma 2019
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Lupin’s Ankleshwar Facility Wins Gold Award - American Society for Quality
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India Pharma Leader Award - India Pharma 2020 and India Medical Device 2020
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“BEST Award” from ATD – 2019
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Excellence in Corporate Social Responsibility – India Pharma 2019
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IDMA Corporate Citizen Award 2019 – Lupin Foundation
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Lupin ranked No.1 in the Biotech and Pharma , and amongst Top 50 large organisations
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in the list of top 100 – Great Place to Work 2019
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Dr. Desh Bandhu Gupta inducted into the ‘Hall of Fame’, CNBC-TV18 – India Business Leader Awards 2018
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Vinita Gupta: Vogue and IBM Businesswoman of the year, listed in Top 50 Most Powerful Women in Business by Fortune India – 2018
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Bulk Drug Company of the Year 2018 - Department of Pharmaceuticals, Govt. of India
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PG 9
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Business Review
Lupin Today
Leading global pharmaceutical player
Financial Metrics
Globally
Major Markets
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Market Cap [(3)] INR 401.6 bn 8 [th] 3 [rd ] 3 [rd ] 6 [th] 4 [th]
Revenue (FY20) INR 151.4 bn Largest Generic Largest Indian Largest in the India Pharma Largest South
Pharma US Market Rank [2] Africa Generics
company
EBITDA (FY20) INR 28.4 bn (by sales [1] ) (by global sales [1] ) (by prescriptions [2] ) (by prescriptions [2] )
1
1
FY20 Revenues split 3
API
12
9% 1
2
1
India Manufacturing
US 1
34% Research
38%
◼ 430 US ANDAs;
◼ 12 USFDA inspected sites
15 7 272 approved
EM's Developed (Ex-US) ◼ 30 bn+ extended Mfg. sites R&D sites ◼ 43 pending US
6% unit capacity
13%
First to Files
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PG 11
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As of 28[th] May 2020
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LTM sales available as of Dec 2019
-
IQVIA MAT Mar-20 for respective markets
Q4 FY2020 Snapshot
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Sales [1] (INR mn, YoY Growth)
India, North America,
11,921, 13% 15,791, (9%)
Total
37,910, (0.4%)
APAC, 1,447,
(16%)
EMEA,
API,
LATAM,
3,286, 13% 3,650, 7%
1,353, (2%)
EBITDA R&D
INR 7,339 mn INR 3,442 mn
19.4% 9.1%
% of Sales % of Sales
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Mr. Nilesh.D.Gupta Managing Director Lupin Limited
“We closed the year with strong growth across all our key markets, and significant strengthening of our profitability and balance sheet. We have had strong momentum in our two major markets, the US and India, and on compliance across our facilities. Importantly, in the current times, we have been able to ensure business continuity while safeguarding the health and safety of our employees”
Important developments
Commercial
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Robust growth in US led by seasonality and Levothyroxine ramp up
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India Region Formulations outperformed (15% YoY)
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Solosec[TM] - Preferred Status on Express Scripts
Pipeline
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Positive CHMP opinion recommending approval of Nepexto (bEnbrel) in EU for all indications
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Positive top-line results in Phase 3 clinical trials for single-dose Solosec[TM] in Trichomoniasis indication
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Tentative approval of gBrovana (inhalation)
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Another inhalation (MDI) product filed in the US
Regulatory
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EIR’s for Vizag, Nagpur, Aurangabad, Pithampur Unit I, Mandideep Unit II, Coral Springs in Mar-May’20
-
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• ‘Quality First’ program rolled out in Goa
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PG 12
Source: 1. Continuing operation
FY2020 Hi hli hts g g
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FY2020 Sales
(INR mn, YoY Growth)
India, North America,
51,385, 11% 58,212, 4%
Total
151,428, 6%
APAC,
6,143, 8%
EMEA,
API, LATAM, 12,364, 4%
12,999 , (4%) 5,600, 9%
EBITDA R&D
INR 28,386 mn INR 15,538 mn
18.7% 10.3%
% of Sales % of Sales
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Important developments
Commercial
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Divested Japan Generics businesses (Kyowa and Kyowa CritiCare)
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bEnbrel launched in Japan
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Levothyroxine approval and launch of 3 RLD’s
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Robust growth and consistent performance in India Region Formulations of 13% YoY
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Management team strengthened with the appointment of Johnny Mikell, Jon Stelzmiller, J. Alan Butcher and Ramesh Swaminathan
Pipeline
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23 US Filings (21 ANDAs & 2 NDAs) with 3 Injectable and 1 Inhalation Filing
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MEK Inhibitor licensed to Boehringer Ingelheim, our 2[nd] NCE licensing deal
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Positive CHMP Opinion for bEnbrel in EU for all indications
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Advanced Inhalation pipeline; 1[st] injectable launched in the US
Regulatory
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‘Quality First’ - Global Quality transformation program rolled out
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8 sites received consecutive positive outcomes from major agencies (Mar-May’20)PG 13
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PG 13
Source: 1. Continuing operation
Ke Exce tional Items – FY2020 y p
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Kyowa Divestiture
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Gavis Impairment
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Divested entire stake (99.82%) in our erstwhile Japanese subsidiary, Kyowa Pharmaceutical to Unison Capital. The deal was concluded on December 17, 2019
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Prior to that, had divested Kyowa’s erstwhile subsidiary Kyowa CritiCare (injectable business) in August 2019
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The above transactions resulted in a total pre-tax exceptional gain of INR 12.2 bn and subsequent tax charge of INR 2.9 bn
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Changes in the pipeline value of Gavis portfolio, resulted in reassessment of the fair value of Gavis and exceptional impairment charge of INR 15.9 bn for FY20
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Re-measurement of deferred tax assets pertaining to Gavis amounted to INR 4.01 bn charge for FY20
-
Total exceptional impairment charge related to Gavis of ~INR 19.9 bn (~US$ 285 mn) for FY20
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Net exceptional gain of ~INR 9.3 bn for FY20 pertaining to divesture of Japan Generics business
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On account of the above exceptional items, we expect (i) ROCE improvement and (ii) Lower amortization expense
in the consolidated financials on an annualized basis
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Financial Results Review
P&L Highlights – Q4 FY2020
| Amount in INR mn | Q4 FY20 | % of sales |
Q3 FY20 | % of sales |
QoQ growth |
Q4 FY19 | % of sales |
YoY growth |
|---|---|---|---|---|---|---|---|---|
| Net sales | 37,910 | 100.0% | 37,161 | 100.0% | 2.0% | 38,070 | 100.0% | (0.4%) |
| Other operating income | 547 | 532 | 796 | |||||
| Total revenue | 38,457 | 37,693 | 2.0% | 38,866 | (1.1%) | |||
| Gross profit (excl. other operating income) |
23,860 | 62.9% | 23,568 | 63.4% | 1.2% | 26,246 | 68.9% | (9.1%) |
| EBITDA | 7,339 | 19.4% | 5,227 | 14.1% | 40.4% | 8,525 | 22.4% | (13.9%) |
| PBT before exceptional item | 4,123 | 10.9% | 1,809 | 4.9% | 127.9% | 5,492 | 14.4% | (24.9%) |
| Exceptional item | (831)1 | 2,887 | - | (22)[2] | - | - | ||
| PBT after exceptional item | 4,954 | 13.1% | (1,078) | (2.9%) | NA | 5,514 | 14.5% | (10.2%) |
| Profit after Tax | 3,903 | 10.3% | (8,748) | (23.5%) | NA | 2,572 | 6.8% | 51.8% |
| Net Profit from continuing operations | 3,896 | 10.3% | (8,685) | (23.4%) | NA | 2,518 | 6.6% | 54.7% |
| Profit/(Loss) from discontinued operations | 0 | 0% | 335 | 0.9% | - | 378 | - | NA |
| Profit/(Loss) for the period | 3,896 | 10.3% | (8,350) | (22.5%) | NA | 2,896 | 7.6% | 34.5% |
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For Q4FY20 : [1] Exceptional item includes (i) Profit on Divestment of Kyowa Pharmaceutical: INR 1,210 mn, (ii) Loss on Divestment of Kyowa Criticare: INR 284 mn & (iii) Impairment of Intangible Assets: INR 96 mn For Q4FY19 : [2] Exceptional item includes provision for fine related to Perindopril Litigation
For Q3FY20 : (3) Tax includes the impact of Exceptional items as (i) Divestiture of Japan Operations: Tax Reversal of INR 65 mn and (ii) Impairment of Gavis Assets triggering a reversal of the Deferred Tax Assets: Tax Reversal of INR 43 mn
PG 16
P&L Hi hli hts – FY2020 g g
| Amount in INR mn | FY20 | % of sales | FY19 | % of sales | YoY growth |
|---|---|---|---|---|---|
| Net sales | 151,428 | 100.0% | 143,181 | 100.0% | 5.8% |
| Other operating income | 2,320 | 3,465 | |||
| Total revenue | 153,748 | 146,646 | 4.8% | ||
| Gross profit (excl. other operating income) |
97,122 | 64.1% | 93,720 | 65.5% | 3.6% |
| EBITDA | 28,386 | 18.7% | 28,937 | 20.2% | (1.9%) |
| PBT before exceptional item | 15,054 | 9.9% | 17,452 | 12.2% | (13.7%) |
| Exceptional item1 | 7,521 | 3,400 | - | ||
| PBT after exceptional item | 7,533 | 5.0% | 14,052 | 9.8% | -46.4% |
| Profit after Tax | (4,038) | (2.7%) | 5,173 | 3.6% | NA |
| Net Profit from continuing operations | (3,995) | (2.6%) | 5,121 | 3.6% | -178.0% |
| Profit/(Loss) from discontinued operations | 1,301 | 0.9% | 945 | 0.7% | 37.7% |
| Profit/(Loss) for the period | (2,694) | (1.8%) | 6,066 | 4.2% | -144.4% |
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- [1] Exceptional item include (i) Profit on Divestment of Kyowa Pharmaceutical: INR 14,121 mn (ii) Loss on Divestment of Kyowa Criticare: INR 1,957 mn (iii) Impairment of Intangible Assets: INR 15,893 mn and (iv) Settlement with State of Texas: INR 3,792 mn
(2) Tax includes the impact of Exceptional items as (i) Divestiture of Japan Operations. INR 2,876 mn and (ii) Impairment of Gavis Assets triggering a reversal of the Deferred Tax Assets: INR 4,011 mn
PG 17
Q4FY20 YoY QoQ
42% 35%
North America
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Strong QoQ growth on seasonality & Levo ramp up
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US quarterly sales ($ mn)
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245 30% average
218
212
market share [1]
184 186
Q4 FY19 Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20
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US portfolio progressing
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8
158
8 174 158 ANDA filings Products Filings pending (during the quarter) marketed approval (cumulative) (cumulative)
4.1% 14.7%
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Consolidating our position in the US [1]
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3
#4 #3
129
#4 123
#5 109
#6
83
79
65 63
57
51
44 45
28
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2014-15 2015-16 2016-17 2017-18 2018-19 2019-20 No. of Products (mkt leader) Top 3 by mkt share US Rx pharma ranking
-
Levothyroxine: Further build up expected in FY21
-
Solosec[TM] - New operating model with improved cost basis and virtual capabilities, in place
-
Covid-19 usage medicines – Further progress with FDA on Albuterol; Doubled capacity and adding US site for Azithromycin (#1 market share)
-
43 FTF’s incl. 14 exclusive FTF await USFDA approval
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PG 18
Note: 1. IQVIA Mar-20
Q4FY20 31% YoY QoQ 10.8% 8.1%
India
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India business continues to be robust
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Leadership across cardiac, diabetes, and respiratory
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| 4 Year CAGR% |
Lupin Rank 1 |
|||||
| Therapy | Market | Lupin | MAT Mar - 16 |
MAT Mar - 20 |
||
| Acute | 9% | 7% | 13 | 13 | ||
| Chronic | 11% | 15% | 5 | 4 | ||
| Cardiac | 10% | 11% | 3 | 3 | ||
| Anti - diabetics |
14% | 23% | 5 | 3 | ||
| Respiratory | 11% | 16% | 3 | 2 | ||
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India quarterly Sales (INR bn)
13.1 13.4 13.0
11.9
10.5
Q4 FY19 Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20
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Strong portfolio
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- India Region Formulations up 15% YoY in Q4FY20 (9.6% for IPM[1] ); up 13% YoY in FY20 (vs 10.8% for IPM[1] )
| BRANDS GLUCONORM-G |
RANK (MAT Mar’20) 40 |
for IPM1); up 13% YoY in FY20 (vs 10.8% for IPM1) | |||||
| 3 brands in Top | HUMINSULIN | 66 | • 62% Chronic contribution1; Our chronic segment grew | ||||
| 100 | BUDAMATE GIBTULIO |
95 155 |
17% against 13% chronic market growth in Q4FY20 | ||||
| ONDERO | 189 | • PCPM tracking at INR 0.73 mn in FY20 (INR 0.70 mn | in | ||||
| 10 brands in Top | TONACT | 191 | FY19; INR 0.63 mn in FY18) | ||||
| 300 | RABLET – D CIDMUS |
264 268 |
• Three new divisions (Dermatology, Urology & Pediatric | ||||
| IVABRAD | 289 | Respiratory) launched in FY20 | |||||
| ONDERO MET | 293 | ||||||
PG 19
Note:
- IQVIA Mar-20
Other Markets
-
Germany: EUR 9.3 mn sales in Q4 FY20 (up 31% YoY). EUR 36.2 mn sales in FY20 (up 26% YoY)
-
• ARV’s, Inhalation and CNS are the key focus therapeutic segments
-
• NaMuscla[[TM]] - Broadening direct presence and partnering with country specific distribution partners
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• 4[[th]] largest generics player[[1]] • Biosimilar Etanercept approved in Australia
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EU5 • ARV’s, Inhalation and CNS are the key focus therapeutic segments • NaMuscla[[TM]] - Broadening direct presence and partnering with country specific distribution partners
-
• 4[[th]] largest generics player[[1]]
-
Australia • Biosimilar Etanercept approved in Australia
-
• 4[th ] largest Rx generics player[2] ; Market leader in CVS space
-
South Africa • Q4 FY20 revenues were ZAR 374 mn (up 9% YoY); FY20 revenues up 5% YoY to ZAR 1,219 mn
-
• BRL 37 mn sales in Q4 FY20 (up 3% YoY); BRL 177 mn sales in FY20 (up 22% YoY)
-
Brazil • Outperformed market growth across the generics and OTC segment
-
• MXN 172 mn sales in Q4FY20; MXN 691 mn sales in FY20 (up 2% YoY)
-
Mexico • #2 (in units) ophthalmic player
-
•
-
API + Global API revenues grew 13% YoY in Q4 FY20; INR 13 bn sales in FY20 Institutional • Continued leadership in anti-TB Institutional business Note: 1. IQVIA Mar-20
PG 20
ears R&D Investment – US$1 bn+ on R&D over the last 4 y
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R&D spend (US$ mn)
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Strong FTF/Complex Gx launch pipeline (projection)
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| 11.9% 10.5% 13.5% 11.7% 10.3% |
11.9% 10.5% 13.5% 11.7% 10.3% |
11.9% 10.5% 13.5% 11.7% 10.3% |
11.9% 10.5% 13.5% 11.7% 10.3% |
11.9% 10.5% 13.5% 11.7% 10.3% |
||
|---|---|---|---|---|---|---|
| 11.7% | 13.5% | 11.9% | 10.5% | 10.3% | ||
| 240 337 277 227 227 FY 16 FY 17 FY 18 FY 19 FY 20 R&D (US $ mn) R&D as % of Sales |
||||||
| Expected number of launches through FY25E FY21 FY22 FY23 FY24 FY25 Targeted Market Size (US $ bn) of brands + generics in complex / FTF categories |
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PG 21
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Regulatory Update
Quality and Compliance- Staying the Course
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8 sites received consecutive positive outcomes from USFDA and other major agencies
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| Agency | Site | Status |
|---|---|---|
| USFDA | Coral Spring, US | EIR in Mar-20 |
| Aurangabad | EIR in Apr-20 | |
| Nagpur | EIR in Apr-20 | |
| Mandideep Unit-2 | EIR in Apr-20 | |
| Pithampur Unit-1 | EIR in Apr-20 | |
| Vizag | EIR in May-20 | |
| MHRA UK | Pithampur Unit-1, 2 and 3 | GMP Certificate received in May-20 (valid for 3 years) |
| Cofepris Mexico | Mandideep Unit-2 | GMP Certificate received in Apr-20 (valid for 2 years) |
| Multiple initiatives spearheaded by Global Quality Teams and Teams underway In FY21, we target to continue the positive momentum, through robust Manufacturing efforts in implementing important initiatives like Quality First as well as undertaking specific remediation activities |
Multiple initiatives spearheaded by Global Quality Teams and Teams underway In FY21, we target to continue the positive momentum, through robust Manufacturing efforts in implementing important initiatives like Quality First as well as undertaking specific remediation activities
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PG 23
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THANK YOU
SEE WWW.LUPIN.COM FOR DETAILS FOLLOW US ON
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