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2 2  {{toc/}}
3 3  {{/box}}
4 4  
5 -Company Overview
5 += Company Overview =
6 6  
7 +Founded in Year 1977, Glenmark Pharmaceuticals (NSE: GLENMARK) is a global pharmaceutical company with a remarkable track record of achievement and improving patients’ lives with access to affordable medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, the company launched its first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States. Over the course of more than 40 years, Glenmark has transformed itself into a burgeoning pharmaceutical company, with operations in more than 80 countries. {{footnote}}https://glenmarkpharma-us.com/about-us/who-we-are/{{/footnote}}
7 7  
8 -Founded in Year 1977, Glenmark Pharmaceuticals (NSE: GLENMARK) is a global pharmaceutical company with a remarkable track record of achievement and improving patients’ lives with access to affordable medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, the company launched its first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States. Over the course of more than 40 years, Glenmark has transformed itself into a burgeoning pharmaceutical company, with operations in more than 80 countries.
9 -
10 -
11 -[[https:~~/~~/glenmarkpharma-us.com/about-us/who-we-are/>>url:https://glenmarkpharma-us.com/about-us/who-we-are/]]
12 -
13 13  Glenmark has the stability, resources and talent to work on solving serious medical problems, all while doing the right thing for patients, people and communities.
14 14  
15 15  
12 +[[image:GLENMARK0.jpg||height="402" width="714"]]
16 16  
17 17  
15 +== R&D Pipeline ==
18 18  
19 -R&D Pipeline
20 -
21 21  Glenmark’s R&D is committed to identifying products that fulfill unique and unmet medical needs in inflammation disorders, especially in respiratory and dermatology therapies and also oncology.
22 22  
23 -<img>
24 24  
20 +[[image:GLENMARK1.png]]
25 25  
26 26  
27 -Plant Locations
23 +== Plant Locations ==
28 28  
25 +=== Manufacturing Facilities ===
29 29  
30 -Manufacturing Facilities
27 +**Formulations**
31 31  
32 -Formulations
29 +* Satpur, Nashik, Maharashtra
30 +* Bardez, Goa
31 +* Unit - I,Teh Baddi, Dist. - Solan, HP
32 +* Unit - II,Teh Nalagarh, Dist.- Solan, HP
33 +* Unit - III,Baddi-Nalagarh Road, Dist. - Solan, HP
34 +* Pithampur, Indore, Madhya Pradesh
35 +* Aurangabad, Maharashtra
36 +* East Sikkim, Sikkim
37 +* Vysoke Myto, Czech Republic
38 +* Buenos Aires, Argentina
39 +* Monroe,USA
33 33  
41 +=== R&D Centres ===
34 34  
35 -Satpur, Nashik, Maharashtra
43 +* Vashi, Navi Mumbai, Maharashtra
44 +* Nashik, Maharashtra
45 +* Raigad, Maharashtra
36 36  
37 -Bardez, Goa
47 +**Clinical Research Centre**
38 38  
39 -Unit - I,Teh Baddi, Dist. - Solan, HP
49 +* Turbhe, Navi Mumbai, Maharashtra
40 40  
41 -Unit - II,Teh Nalagarh, Dist.- Solan, HP
51 +=== ICHNOS Sciences ===
42 42  
43 -Unit - III,Baddi-Nalagarh Road, Dist. - Solan, HP
53 +**Global Clinical Development Centre**
44 44  
45 -Pithampur, Indore, Madhya Pradesh
55 +* Paramus, NJ, USA
46 46  
47 -Aurangabad, Maharashtra
57 +**R&D Centres**
48 48  
49 -East Sikkim, Sikkim
59 +* Epalinges Switzerland
60 +* La Chaux-de-fonds, Switzerland
50 50  
51 -Vysoke Myto, Czech Republic
62 +**Manufacturing Facility**
52 52  
53 -Buenos Aires, Argentina
64 +* La Chaux-de-fonds, Switzerland
54 54  
55 -Monroe,USA
66 +=== Glenmark Life Sciences ===
56 56  
68 +* Ankleshwar, Dist. Bharuch,Gujarat
69 +* Solapur, Maharashtra
70 +* Daund, Pune, Maharashtra
71 +* Dahej District, Bharuch, Gujarat
57 57  
73 +[[image:GLENMARK3.png]]
58 58  
59 59  
60 -R&D Centres
76 += Industry Overview =
61 61  
78 +**Global Pharma Scenario**
62 62  
63 -Vashi, Navi Mumbai, Maharashtra
80 +The global pharmaceutical landscape is undergoing a major overhaul with the advent of new technologies and more efficient and cost-effective manufacturing processes. This is paving the way for a whole new world of drugs and treatments of the future. In 2019, the global pharmaceutical industry was worth approximately $1.2 trillion, a figure predicted to increase to around $1.5 trillion by 2023. And the global generic industry is expected to be worth $474 billion by 2023, a 6.8% increase from 2018. {{footnote}}https://www.glenmarkpharma.com/sites/default/files/ANNUAL_REP0RT_2020_1.pdf{{/footnote}}
64 64  
65 -Nashik, Maharashtra
66 66  
67 -Raigad, Maharashtra
68 -
69 -
70 -Clinical Research Centre
71 -
72 -
73 -Turbhe, Navi Mumbai, Maharashtra
74 -
75 -
76 -ICHNOS SCIENCES INC.
77 -
78 -Global Clinical Development Centre
79 -
80 -
81 -Paramus, NJ 07652, USA
82 -
83 -
84 -R&D Centres
85 -
86 -Epalinges Switzerland
87 -
88 -La Chaux-de-fonds, Switzerland
89 -
90 -
91 -Manufacturing Facility
92 -
93 -
94 -La Chaux-de-fonds, Switzerland
95 -
96 -
97 -GLENMARK LIFE SCIENCES
98 -
99 -
100 -Ankleshwar, Dist. Bharuch,Gujarat
101 -
102 -Solapur, Maharashtra
103 -
104 -Daund, Pune, Maharashtra
105 -
106 -Dahej District, Bharuch, Gujarat
107 -
108 -
109 -Industry Overview
110 -
111 -
112 -Global Pharma Scenario
113 -
114 -The global pharmaceutical landscape is undergoing a major overhaul with the advent of new technologies and more efficient and cost-effective manufacturing processes. This is paving the way for a whole new world of drugs and treatments of the future. In 2019, the global pharmaceutical industry was worth approximately $1.2 trillion, a figure predicted to increase to around $1.5 trillion by 2023. And the global generic industry is expected to be worth $474 billion by 2023, a 6.8% increase from 2018.
115 -
116 -[[https:~~/~~/www.glenmarkpharma.com/sites/default/files/ANNUAL_REP0RT_2020_1.pdf>>url:https://www.glenmarkpharma.com/sites/default/files/ANNUAL_REP0RT_2020_1.pdf]]
117 -
118 118  API manufacturing quality is most often a key indicator for the performance of pharmaceutical markets – with many of the pharma’s developed markets still perceived as ahead of the large volume producers. According to a 2019 CPhI report, Japan has pushed ahead of Germany with a respectable growth of 2.5%, to now holding the number one spot for API manufacturing quality. With regard to innovation, the USA continues to retain its top position. It also boasts the largest growth increase (2.5%) of all assessed markets, while Japan and Germany remain in second and third position respectively. The ever-increasing demand for pharmaceuticals and the push for more accessible and affordable drugs is fueling the biosimilar market to grow exponentially in the coming years. There is also growing interest from pharma companies to tap the rare and specialty disease markets. Innovations in advanced biologics, nucleic acid therapeutics, cell therapies, bioelectronics and implantables are attracting huge investments even from non-pharma companies like Facebook, Qualcomm etc.
119 119  
120 120  
121 -Business Overview
86 += Business Overview =
122 122  
88 +== India Formulations ==
123 123  
124 -India Formulations
125 -
126 126  During the year 2019-20, the India Formulations (IF) business performed well, registering revenue of Rs. 32021.67 Mn (USD 452.41 Mn) as against Rs. 27,769.71 Mn (USD 398.07 Mn) in the previous year, recording growth of 15.31%. The India business continues to be a strong contributor to the company’s overall growth, with the fourth quarter being an exceptional quarter in terms of growth.
127 127  
128 128  As per IQVIA MAT Mar 2020, the IF business is ranked 14th in the Indian pharmaceutical market. The highlight for the India business has been the launch of Remogliflozin, a novel anti-diabetic drug in the SGLT2 inhibitor class of molecules. Glenmark was the first company to launch this product in India. Since its launch, Remogliflozin continues to do exceedingly well in the market and is well received in the medical community. It has achieved impressive market penetration of 34% in the SGLT2 segment, a figure that is progressing month on month. Glenmark now ranks third in the respiratory segment in the Indian pharmaceutical market. In the cardiology space, the most notable brand remains Telma, which is the first Glenmark brand to feature in the top 20 IPM Brands. It has jumped 11 ranks in the last 12 months (IQVIA Mar’20).
129 129  
130 130  
131 -US Formulations
95 +== US Formulations ==
132 132  
133 133  For the financial year 2019-20, the US business registered revenue from the sale of finished dosage formulations of Rs. 31,404.49 Mn (USD 443.69 Mn) as against revenue of Rs. 31,392.70 Mn (USD 450.01 Mn) for the previous corresponding year.
134 134  
... ... @@ -137,12 +137,12 @@
137 137  As part of a distribution agreement with Elite Laboratories, Glenmark also launched Isradipine Capsules. During this financial year, the US business was significantly impacted in terms of sales on account of three products viz. Mupirocin Cream, Atomoxetine hydrochloride & Calcipotriene cream. Sales were also impacted due to the Ranitidine issue in the US market. Glenmark’s marketing portfolio through March 31, 2020 consists of 165 generic products authorized for distribution in the U.S. market. The company currently has 44 applications pending in various stages of the approval process with the US FDA, of which 24 are Paragraph IV applications.
138 138  
139 139  
140 -Rest of The World
104 +== Rest of The World ==
141 141  
142 142  For the fiscal year 2019-20, revenue from Africa, Asia and CIS region was Rs.12,854.45 Mn (USD 181.61 Mn) as against Rs. 12,759.35 Mn (USD 182.90 Mn) for the previous corresponding year, recording growth of 0.75%.
143 143  
144 144  
145 -Russia/CIS Region
109 +=== Russia/CIS Region ===
146 146  
147 147  According to IQVIA MAT March’20 data, Glenmark Russia recorded faster than market growth of +10.7% in value v/s overall retail market growth of +8.9%. In the dermatology segment, Glenmark ranks 11 amongst dermatology companies present in the retail market on MAT March’20 basis. The introductions under the Oflo umbrella i.e. Oflomil nail lacquer and Oflomycol cream & solution will further strengthen the company’s position in this segment. In the respiratory space, Glenmark continues to secure a strong position and ranks 4th, as per MAT March’20 data amongst the companies present on the expectorants market (retail segment) of the local pharmaceutical market. Launch of Momate Rhino OTC helped to further strengthen Glenmark’s respiratory franchise in the Russian market.
148 148  
... ... @@ -149,12 +149,12 @@
149 149  During the year under review, Glenmark’s Ukraine business showed growth of 25.5% in units
150 150  
151 151  
152 -Asia & Africa
116 +=== Asia & Africa ===
153 153  
154 154  For the fiscal year 2019-20, sales in the Asia region continued to remain subdued across all markets. The Africa region recorded strong secondary sales growth during the year. All the major subsidiaries viz. South Africa and Kenya recorded good growth. The company has also made good progress in expanding its presence in the GCC region
155 155  
156 156  
157 -Europe Formulations
121 +=== Europe Formulations ===
158 158  
159 159  Glenmark Europe’s operations for the fiscal year 2019-20, recorded revenue at Rs. 12,484.48 Mn (USD 176.38 Mn) as against Rs. 11,207.09 Mn (USD 160.65 Mn), recording growth of 11.40%.
160 160  
... ... @@ -161,12 +161,12 @@
161 161  Western European business continued expanding through increased penetration in the UK, Germany, Spain and the Netherlands while Nordic countries witnessed some de-growth. During the year under review, the Central Eastern European region also managed to grow well in constant currency with major markets witnessing sales growth. During the year under review, GSK concluded a settlement agreement concerning the existing litigation against Glenmark and Celon regarding the shape of their inhalation product containing salmeterol xinafoate and fluticasone propionate, named Salmex (aka Stalpex, Salflutin and Asthmex) in selected European markets.
162 162  
163 163  
164 -Latin America
128 +=== Latin America ===
165 165  
166 166  Glenmark’s revenue for the year from its Latin American and Caribbean operations was at Rs. 5355.57 (USD 75.66 Mn) for FY 2019-20, as against Rs. 4179.53 Mn (USD 59.91 Mn) for the previous corresponding year, recording growth of 28.14%. In June 2019, Glenmark announced that its Brazilian subsidiary has entered into an exclusive partnership agreement with Novartis AG, for three respiratory products indicated for treatment of Chronic Obstructive Pulmonary Disease (COPD) in Brazil. The products involved in the agreement are Seebri® (Glycopyrronium bromide), Onbrize® (Indacaterol) and Ultibro® (combination of Indacaterol and Glycopyrronium).
167 167  
168 168  
169 -Glenmark Life Sciences
133 +=== Glenmark Life Sciences ===
170 170  
171 171  
172 172  Glenmark Life Sciences primarily includes manufacturing and marketing of Active Pharmaceutical Ingredient (API) products across all major markets globally. It also includes captive sales (i.e. use of API by GPL for its own formulations).
... ... @@ -176,21 +176,20 @@
176 176  GLS has three US FDA approved API manufacturing facilities (Ankleshwar, Dahej and Mohol). In July 2019, the US FDA and Health Canada jointly inspected the Ankleshwar manufacturing facility of GLS. Subsequently the U.S. FDA issued the EIR for the facility and Health Canada has rated the facility as “Compliant.”
177 177  
178 178  
179 -Financial Overview
143 +[[image:GLENMARK2.jpg]]
180 180  
181 181  
146 += Financial Overview =
147 +
182 182  On Standalone basis the Company achieved gross revenue of Rs 67,126.31 million as compared to Rs 63,048.67 million in the previous year and the Standalone operating profit before tax and exceptional item was Rs 15,160.90 million as compared to Rs 14,729.99 million in the previous year.
183 183  
184 184  On Consolidated basis the Company achieved a gross revenue of Rs 106,409.69 million and the Consolidated operating profit before tax and exceptional item was Rs 10,632 million as compared to Rs 11,334.47 million in the previous year.
185 185  
186 186  
153 +== Highlights for Q3 FY 2020-21 ==
187 187  
188 -Highlights for Q3 FY 2020-21
155 +February 12, 2021: : Glenmark Pharmaceuticals Limited announced its financial results for the third quarter ended December 31 of the financial year 2020-21. {{footnote}}https://www.glenmarkpharma.com/sites/default/files/Glenmarks-consolidated-sales-risesin-q3.pdf{{/footnote}}
189 189  
190 -February 12, 2021: : Glenmark Pharmaceuticals Limited announced its financial results for the third quarter ended December 31 of the financial year 2020-21.
191 -
192 -[[https:~~/~~/www.glenmarkpharma.com/sites/default/files/Glenmarks-consolidated-sales-risesin-q3.pdf>>url:https://www.glenmarkpharma.com/sites/default/files/Glenmarks-consolidated-sales-risesin-q3.pdf]]
193 -
194 194  For the third quarter of FY 2020-21, Glenmark’s consolidated sales was at Rs. 27,605.07 Mn. as against Rs. 26,574.51 Mn. recording an increase of 3.88 %.
195 195  
196 196  For the third quarter of FY 2020-21, Glenmark’s consolidated revenue (incl. other revenue) was at Rs. 27,867.63 Mn. as against 27,355.62 recording an increase of 1.87 %.
... ... @@ -203,21 +203,19 @@
203 203  “The company's India business continued to grow at a healthy pace in the third quarter, consistently outperforming industry growth. The US business rebounded well and the company expect the business to gradually build sales momentum. This quarter, the API business once again performed well and the company expect this business to grow in the next few years. The company also expect the European and the emerging markets business to gain traction in the coming few quarters” said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals.
204 204  
205 205  
206 -India Formulations
169 +**India Formulations**
207 207  
208 208  Sales from the formulation business in India for the Third Quarter of FY 2020-21 was at Rs. 8,821.19 Mn. as against Rs. 7,888.39 Mn. in the previous corresponding quarter, recording growth of 11.82 %.
209 209  
210 -The India business continues to significantly outperform industry growth rates, continuing the trend of the past several years. As per IQVIA data, Glenmark remains the second fastest growing company in the industry among the Top 20 players on a MAT Dec 2020 basis with growth of 15.8% as compared to IPM (Indian Pharma market) growth of 6.12%. On a quarterly basis, as per IQVIA, the business recorded growth of 15.11% as compared to 9.75% for the market.
173 +The India business continues to significantly outperform industry growth rates, continuing the trend of the past several years. As per IQVIA data, Glenmark remains the second fastest growing company in the industry among the Top 20 players on a MAT Dec 2020 basis with growth of 15.8% as compared to IPM (Indian Pharma market) growth of 6.12%. On a quarterly basis, as per IQVIA, the business recorded growth of 15.11% as compared to 9.75% for the market. {{footnote}}https://www.glenmarkpharma.com/sites/default/files/Glenmarks-consolidated-sales-risesin-q3.pdf{{/footnote}}
211 211  
212 212  
213 -USA Formulations
214 -
215 215  Glenmark Pharmaceuticals Inc., USA registered revenue from sale of finished dosage formulations of Rs.7,803.87 Mn. for the quarter ended Dec 31, 2020 as against revenue of Rs.7,998.28 Mn. for the previous corresponding quarter, recording decline in revenue by (2.43%). However, the business recorded quarter on quarter growth of 4.4 % in USD terms.
216 216  
217 217  Glenmark’s marketing portfolio through December 31, 2020 consists of 167 generic products authorized for distribution in the U.S. market. The Company currently has 44 applications pending in various stages of the approval process with the US FDA, of which 22 are Paragraph IV applications.
218 218  
219 219  
220 -Europe Formulations
181 +**Europe Formulations**
221 221  
222 222  Glenmark Europe’s revenue for the third quarter of FY 2020-21 was at Rs. 3,133.29 Mn as against Rs. 3,089.36 Mn in the previous corresponding quarter, recording a growth of 1.42%.
223 223  
... ... @@ -224,17 +224,17 @@
224 224  Glenmark’s European business remained weak in the third quarter mainly impacted by the enhanced lockdown measures due to heightened pandemic concerns in most key markets. This resulted in sales decline recorded in both the Central Eastern European region and the Western European region. Glenmark continues to increase penetration across major markets in Western Europe. For the financial year, the European region signed 12 major contracts for in-licensing products from various companies across its operating markets in the region. The Czech and Slovak subsidiaries launched three products during the quarter. The German subsidiary launched two products and the Spain unit launched one product during the third quarter
225 225  
226 226  
227 -Africa, Asia and CIS Region (ROW)
188 +**Africa, Asia and CIS Region (ROW)**
228 228  
229 229  For the third quarter of FY 2020-21, revenue from Africa, Asia and CIS region was at Rs.3,360.37 Mn. as against Rs. 3,413.74 Mn. for the previous corresponding quarter, recording decline in revenue of (1.56%).
230 230  
231 231  
232 -Latin America
193 +**Latin America**
233 233  
234 234  Glenmark’s revenue from its Latin American & Caribbean operations was at Rs. 1,285.65 Mn. for the third quarter of FY 2020-21 as against Rs. 1,563.18 Mn., recording revenue decline of 17.75 %. The pandemic continues to impact the Brazilian business and the unit once again recorded decline in sales for the quarter as compared to the previous corresponding quarter. The Mexico subsidiary performed relatively better recording sales growth for the quarter. The entire region continues to witness a challenging environment on account of the pandemic.
235 235  
236 236  
237 -Glenmark Life Sciences (GLS
198 +**Glenmark Life Sciences (GLS)**
238 238  
239 239  For the third quarter of the financial year, Glenmark Life Sciences Limited registered consolidated revenue including captive sales of Rs. 5,006 Mn as against Rs. 4,092 Mn, recording growth of 22.35 %.
240 240  
... ... @@ -241,24 +241,25 @@
241 241  The external sales for the API business performed well in the third quarter recording strong growth. The India API business grew over 50 % and the Latam business grew in excess of 30 % in the third quarter. GLS continues to look for opportunities for the Favipiravir API and has already started supplying in a few countries. During the quarter, GLS submitted nine new DMFs across various operating markets. The company is looking to file at least 10 -12 DMFs in the fourth quarter of the financial year.
242 242  
243 243  
244 -ICHNOS Sciences
205 +**ICHNOS Sciences**
245 245  
246 246  For the third quarter of the financial year, Glenmark invested Rs 1713 Mn (USD 23.3 Mn) as compared to Rs. 2,108 Mn ( USD 30.01 Mn) invested in the corresponding quarter of the previous financial year. For the first nine months of the current financial year, Glenmark has invested Rs 5693 Mn (USD 76.26 Mn) as compared to Rs 5,943 Mn ( USD 85.03 Mn) invested in the corresponding period of the previous financial year.
247 247  
248 248  
210 += Recent developments =
249 249  
250 -Recent developments
251 251  
213 +Glenmark Pharmaceuticals receives ANDA approval for Chlorpromazine Hydrochloride Tablets USP {{footnote}}https://www.glenmarkpharma.com/sites/default/files/Glenmark-receives-ANDA-approval-for-Chlorpromazine-Hydroch.pdf{{/footnote}}
252 252  
253 -Glenmark Pharmaceuticals receives ANDA approval for Chlorpromazine Hydrochloride Tablets USP
215 +**March 24, 2021;** : Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, the generic version of Thorazine®1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline. 
254 254  
255 -[[https:~~/~~/www.glenmarkpharma.com/sites/default/files/Glenmark-receives-ANDA-approval-for-Chlorpromazine-Hydroch.pdf>>url:https://www.glenmarkpharma.com/sites/default/files/Glenmark-receives-ANDA-approval-for-Chlorpromazine-Hydroch.pdf]]
256 -
257 -
258 -March 24, 2021; : Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, the generic version of Thorazine®1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline. 
259 -
260 260  Glenmark has been granted a competitive generic therapy (CGT) designation for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.
261 261  
262 262  According to IQVIATM sales data for the 12 month period ending January 2021, the Thorazine®1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg market2 achieved annual sales of approximately $108.6 million.
263 263  
264 264  Glenmark’s current portfolio consists of 171 products authorized for distribution in the U.S. marketplace and 41 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
222 +
223 +
224 += References =
225 +
226 +{{putFootnotes/}}
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