MIRA INFORM REPORT

Report No. :	499515
Report Date :	21.03.2018

IDENTIFICATION DETAILS

Name :	MYLAN LABORATORIES LIMITED (w.e.f. 05.10.2011)
Formerly Known As :	MATRIX LABORATORIES LIMITTED (w.e.f. 21.03.2001) HERREN DRUGS AND PHARMACEUTICALS LIMITED (w.e.f. 27.06.1994) HERREN DRUGS LIMITED (w.e.f. 19.10.1992) HERREN DRUGS PRIVATE LIMITED
Registered Office :	House No. 8-2-293/82/J III, Plot No. 564/A/22, Road No.92, Jubilee Hills, Hyderabad – 500033, Telangana
Tel. No.:	91-40-30496666
Country :	India
Financials (as on) :	31.03.2016
Date of Incorporation :	29.11.1984
Com. Reg. No.:	36-005146
Capital Investment / Paid-up Capital :	INR 487.030 Million
CIN No.: [Company Identification No.]	U24231TG1984PLC005146
IEC No.: [Import-Export Code No.]	0988008858
GSTN : [Goods & Service Tax Registration No.]	36AADCM3491M1Z2
TIN No.:	36370135109
TAN No.: [Tax Deduction & Collection Account No.]	Not Available
PAN No.: [Permanent Account No.]	AADCM3491M
Legal Form :	A Closely Held Public Limited Liability Company
Line of Business :	Subject is engaged in the manufacture of Active Pharmaceutical Ingredients, Finished Dosage Formulations, Injectable and research and development activities. [Registered Activity]
No. of Employees :	Information denied by the management

RATING & COMMENTS

(Mira Inform has adopted New Rating mechanism w.e.f. 23^rd January 2017)

MIRA’s Rating :

A+

Credit Rating	Explanation	Rating Comments
A+	Low Risk	Business dealings permissible with low risk of default

Status :	Excellent
Payment Behaviour :	Regular
Litigation :	Exist
Comments :	Subject is a subsidiary of “MP Laboratories (Mauritius) Limited, Mauritius” and was incorporated in the year 1984. It is having excellent track records. As per registrar of companies the date of balance sheet (i.e. financial filed) is shown as 31.03.2017 but the documents related to the financial for the year 2017 are not available from any sources. For the financial year 2016, the company has increased its revenue from operation as compared to previous year but reported losses. However, rating takes into consideration strong financial profile of the company marked by healthy networth base and average debt balance sheet. Further, the company also derives strength from its strong holding company support, established market position along with presence in various therapeutic segments and geographical diversity. However, these rating strengths are partially offset by working capital-intensive operations and exposure to increasing regulatory scrutiny and competition in the global generics market. Trade relations are reported as fair. Payments are reported to be regular. In view of established market position, the company can be considered good for normal business dealings at usual trade terms and conditions.

NOTES:

Any query related to this report can be made on e-mail: infodept@mirainform.com while quoting report number, name and date.

ECGC Country Risk Classification List

Country Name	Previous Rating (30.09.2017)	Current Rating (31.12.2017)
India	A1	A1

Risk Category	ECGC Classification
Insignificant	A1
Low Risk	A2
Moderately Low Risk	B1
Moderate Risk	B2
Moderately High Risk	C1
High Risk	C2
Very High Risk	D

EXTERNAL AGENCY RATING

Rating Agency Name	CRISIL
Rating	Long Term Rating= AA-
Rating Explanation	High degree of safety and low credit risk.
Date	31.03.2017

RBI DEFAULTERS’ LIST STATUS

Subject’s name is not enlisted as a defaulter in the publicly available RBI Defaulters’ list.

EPF (Employee Provident Fund) DEFAULTERS’ LIST STATUS

Subject’s name is not enlisted as a defaulter in the publicly available EPF (Employee Provident Fund) Defaulters’ list as of 31-03-2016.

BIFR (Board for Industrial & Financial Reconstruction) LISTING STATUS

Subject’s name is not listed as a Sick Unit in the publicly available BIFR (Board for Industrial & Financial Reconstruction) list as of 21.03.2018

IBBI (Insolvency and Bankruptcy Board of India) LISTING STATUS

Subject’s name is not listed in the publicly available IBBI (Insolvency and Bankruptcy Board of India) list as of report date.

INFORMATION DENIED BY

Name :	Not Divulged
Designation :	Accounts Department
Contact No.:	91-80-66278000

LOCATIONS

Registered Office :	House No. 8-2-293/82/J III, Plot No.564/A/22, Road No.92, Jubilee Hills, Hyderabad – 500033, Telangana, India
Tel. No.:	91-40-30496666 / 23550543
Fax No.:	91-40-27700343 / 30866699
E-Mail :	mylan.india@mylan.in nagaraj.bodige@mylan.in
Website :	www.mylanlabs.in
Corporate Office :	F-4 and F-12, MIDC Malegaon, Sinnar, Nashik – 422113, Maharashtra, India
Branch Office 1 :	7th Floor, Tower 2B, Indiabulls Centre, 841, Senapati Bapat Marg, Elphinstone Road (West), Mumbai – 400021, Maharashtra, India
Branch Office 2 :	Nirmal, 20^th Floor, Nariman Point, Mumbai – 400021, Maharashtra, India
Factories :	Located at : · Hyderabad (4 Factories) · Maharashtra (2 Factories) · Aurangabad (1 Factory) · Indore (1 Factory) · Andhra Pradesh (2 Factories)

DIRECTORS

AS ON 31.03.2017

Name :

Mr. Rakesh Bamzai

Designation :

Managing Director

Address :

No.79/12, Tuisi Sunny Brooks, Sarjapur Road, Doddakannahalli, Bangalore – 560035, Karnataka, India

Date of Birth/Age :

01.10.1965

Qualification :

B.Sc (Tech)

Date of Appointment :

01.11.2014

PAN No.:

AANPB2957J

DIN No.:

06997113

Other Directorship:

CIN/FCRN	Company Name	Begin Date	End Date
U74999MH2015PLC262055	JAI PHARMA LIMITED	20/11/2015	-

Name :

Ms. Sarada Kalyani Bhagawati

Designation :

Whole-Time Director

Address :

H No. 1-1-380 / 38, Ashok Nagar Extension, Hyderabad – 500020, Telangana, India

Date of Birth/Age :

29.09.1968

Qualification :

CA, ICWA

Date of Appointment :

01.11.2014

PAN No.:

ACXPB3665R

DIN No.:

02680074

Other Directorship:

CIN/FCRN	Company Name	Begin Date	End Date
U24239TG2005PLC047551	ASTRIX LABORATORIES LIMITED	30/09/2009	-
U24230MH1996PTC097728	MADAUS PHARMACEUTICALS PRIVATE LIMITED	26/09/2017	-
U74999MH2015PLC262055	JAI PHARMA LIMITED	20/11/2015	-

Name :

Mr. Rajiv Krishan Luthra

Designation :

Director

Address :

3/15, Shanti Niketan, New Delhi – 110021, India

Date of Birth/Age :

01.08.1957

Qualification :

LL.M

Date of Appointment :

14.08.2015

PAN No.:

AAAPL9458K

DIN No.:

00022285

Other Directorship:

CIN/FCRN	Company Name	Begin Date	End Date
U74140DL2007PTC157347	MYLAN LABORATORIES INDIA PRIVATE LIMITED	03/01/2007	-
L74300MH2005PLC281753	TV18 BROADCAST LIMITED	29/09/2016	-
L70101HR1963PLC002484	DLF LIMITED	29/08/2014	-
U74300DL2008PTC185178	AFC NETWORK INDIA PRIVATE LIMITED	24/11/2008	-
U74899GJ2001PLC096846	LODHI PROPERTY COMPANY LIMITED	29/11/2002	-
U74899DL1996PLC082842	VLCC HEALTH CARE LIMITED	28/06/2016	-
L65910MH1996PLC280969	NETWORK18 MEDIA & INVESTMENTS LIMITED	24/09/2015	-
U73100DL2016NPL290319	PAANI FOUNDATION	28/01/2016	-

Name :

Mr. Mohit Saraf

Designation :

Director

Address :

Farm No 2, Kapashera Village, Farm House, Delhi – 110037, India

Date of Birth/Age :

19.11.1966

Qualification :

LL.M

Date of Appointment :

14.08.2015

PAN No.:

AKAPS4446E

DIN No.:

00057284

Other Directorship:

CIN/FCRN	Company Name	Begin Date	End Date
U74140DL2007PTC157347	MYLAN LABORATORIES INDIA PRIVATE LIMITED	03/01/2007	-
U65993DL2008PTC178222	GIP INVESTMENT ADVISORS (INDIA) PRIVATE LIMITED	26/08/2009	-

Name :

Mr. Malik Rajiv

Designation :

Director

Address :

B-6B, Gangotri Enclave, Alaknanda, New Delhi – 110019, India

Date of Birth/Age :

12.03.1961

Qualification :

M. Pharm (Degree in Pharmaceutical Industry)

Date of Appointment :

01.07.2008

PAN No.:

ADHPM8833H

DIN No.:

00120557

KEY EXECUTIVES

Name :	Mr. Sarada Kalyani Bhagawati
Designation :	Chief Financial Officer
Address :	H. No. 1-1-380/38, Ashok Nagar Extension, Hyderabad – 500020, Telangana, India
Date of Birth/Age :	29.09.1968
Qualification :	CA,ICWA
Date of Appointment :	01.11.2014
PAN No.:	ACXPB3665R
Name :	Mr. Rakesh Bamzai
Designation :	Chief Executive Officer
Address :	No. 79/12, Tulsi Sunny Brooks, Sarjapur Road, Doddakannahalli, Bangalore – 560035, Karnataka, India
Date of Birth/Age :	01.10.1965
Qualification :	B.Sc (Tech)
Date of Appointment :	01.11.2014
PAN No.:	AANPB2957J
Name :	Mr. Nagaraj Goud Bodige
Designation :	Company Secretary
Address :	H. No. 5-14-88, Indiranagar Colony II, APHB Colony, Movlali, Hyderabad – 500040, Telangana, India
Date of Birth/Age :	02.12.1977
Qualification :	Company Secretary, LL.B
Date of Appointment :	25.07.2011
PAN No.:	AGYPB3840P

MAJOR SHAREHOLDERS

AS ON 31.03.2017

Names of Shareholders	No. of Shares
MP Laboratories (Mauritius) Limited, Mauritius	157402332
Mylan Luxembourg 2 S.a.r.l	28508547
Mylan Group B.V.	57601744
B. Hari Babu	2
Sarada Kalyani Bhagawati	2
Yasir Rawjee jointly held with Mylan Luxembourg 2 S.a.r.l.	2
Rajeev Mukundan	2
Susanto Banerjee	2
B. Nagaraj Goud	2
Total	243512635

Equity Share Break up (Percentage of Total Equity)

AS ON 22.09.2017

Category	Percentage
Promoters [Bodies corporate]	100.00
Total	100.00

BUSINESS DETAILS

Line of Business :

Subject is engaged in the manufacture of Active Pharmaceutical Ingredients, Finished Dosage Formulations, Injectable and research and development activities. [Registered Activity]

Products / Services :

Name and Description of main products / services	ITC Code
Atroiza (TEE) Tab 300/600/200 mg C28 ZA Te	30049099
T/L/E TAB 300/300/600 Mg 30 BT PEP A/F	30049099
T/L/E TAB 300/300/600 Mg 30 BT WHO A/F	30049099
T/E/E TAB 300/600/200MG 28BT ZA MY WHO	30049099
Active Pharmaceutical Ingredient	29349900

Brand Names :

Not Available

Agencies Held :

Not Available

Exports :

Not Divulged

Imports :

Not Divulged

Terms :

Not Divulged

PRODUCTION STATUS – (NOT AVAILABLE)

GENERAL INFORMATION

Suppliers :

Reference :	Not Divulged
Name of the Person :	--
Contact No.:	--
Since How Long Known :	--
Maximum Limit Dealt :	--
Experience :	--
Remark :	--

Customers :

Reference :	Not Divulged
Name of the Person :	--
Contact No.:	--
Since How Long Known :	--
Maximum Limit Dealt :	--
Experience :	--
Remark :	--

No. of Employees :

Information denied by the management

Bankers :

Banker Name :	State Bank of India
Branch :	--
Person Name (With Designation) :	--
Contact Number :	--
Name of Account Holder :	--
Account Number :	--
Account Since (Date/Year of Account Opening) :	--
Average Balance Maintained :	--
Credit Facilities Enjoyed (CC/OD/Term Loan) :	--
Account Operation :	--
Remark :	--

Facilities :

SECURED LOANS	31.03.2016 INR In Million	31.03.2015 INR In Million
LONG TERM BORROWINGS
Term loans	75070.300	17499.300
Total	75070.300	17499.300

Auditors :
Name :	Deloitte Haskins and Sells Chartered Accountants
Address :	Gowra Grand, III Floor, 1-8-1-384 and 385, SP Road, Secunderabad – 500003, Telangana, India
PAN No.:	AACFD3771D
Memberships :	Not Available
Collaborators :	Not Available
Holding Company :	· MP Laboratories (Mauritius) Limited
Ultimate Holding Company:	· Mylan Inc., USA (upto 26th Feb 2015) · Mylan N.V., Netherlands (w.e.f. 27th Feb 2015)
Subsidiary Company :	· Famy Care Europe Limited (w.e.f. 21st Nov 2015)
Fellow Subsidiary Companies :	· Mylan Pharmaceuticals Inc. · Mylan Pharmaceuticals ULC · Mylan Seiyaku Limited · Gerard Laboratories Limited · Alphapharm Pty. Limited · Mylan Pharmaceuticals Private Limited · Mylan Pharma UK Limited · Mylan Technologies, Inc. · Mylan S.A.S. · Mylan New Zealand Limited · Xixia Pharmaceuticals (Pty) Limited · Mylan Ireland Limited · Mylan S.p.A · Mylan Institutional Inc. · Mylan Laboratories Inc. · Mylan Luxembourg 2 S.a.r.l · Mylan Luxembourg 8 S.a.r.l · Agila Specialties Polska sp. Z.o.o · Farma Plus AS · Sagent Agila LLC · Agila Specialties Global Pte. Limited · Agila Farmaceutica Participacoes Ltda · Onco Laboratories Limited · Agila Specialties Inc. · Mylan Ireland Holdings Limited · Mylan Foundation, India · Mylan (Pty) Limited · Mylan Teoranta · Mylan Inc., USA (w.e.f 27th Feb 2015) · Agila Especialidades Farmaceutica Ltda. · Mylan Brasil Distribuidora · Mylan Group B.V. · Mylan Luxembourg S.A.R.L · Mylan Taiwan Limited · Mylan FZ LLC · Mylan B.V · Mylan Laboratorios Ltda.

CAPITAL STRUCTURE

AS ON 22.09.2017

Authorised Capital :

No. of Shares	Type	Value	Amount
350000000	Equity Shares	INR 2/- each	INR 700.000 Million

Issued, Subscribed & Paid-up Capital :

No. of Shares	Type	Value	Amount
243512635	Equity Shares	INR 2/- each	INR 487.025 Million

FINANCIAL DATA

[all figures are in INR Million]

ABRIDGED BALANCE SHEET

SOURCES OF FUNDS	31.03.2016	31.03.2015	31.03.2014
I. EQUITY AND LIABILITIES
(1)Shareholders' Funds
(a) Share Capital	487.030	378.560	369.510
(b) Reserves and Surplus	67766.300	45010.120	41421.410
(c) Money received against share warrants	0.000	0.000	0.000
(2) Share Application money pending allotment	0.000	1742.130	0.000
Total Shareholders’ Funds (1) + (2)	68253.330	47130.810	41790.920
(3) Non-Current Liabilities
(a) long-term borrowings	101979.960	67782.740	60339.510
(b) Deferred tax liabilities (Net)	1537.050	3429.760	4010.940
(c) Other long-term liabilities	5341.700	1745.640	0.000
(d) long-term provisions	427.540	354.440	221.290
Total Non-current Liabilities (3)	109286.250	73312.580	64571.740
(4) Current Liabilities
(a) Short-term borrowings	4405.640	1102.410	5399.010
(b) Trade payables	18153.910	16371.760	16111.710
(c) Other current liabilities	10501.290	9932.830	15591.660
(d) Short-term provisions	463.080	318.960	428.300
Total Current Liabilities (4)	33523.920	27725.960	37530.680
TOTAL	211063.500	148169.350	143893.340
II. ASSETS
(1) Non-current assets
(a) Fixed Assets
(i) Tangible assets	34811.900	30990.220	26772.180
(ii) Intangible Assets	73278.470	29109.470	35426.620
(iii) Tangible assets capital work-in-progress	2654.710	1766.270	2562.500
(iv) Intangible assets under development	5392.000	7646.000	7646.000
(b) Non-current Investments	2.330	2.250	24.880
(c) Deferred tax assets (net)	0.000	0.000	0.000
(d) Long-term loans and advances	6553.500	5536.540	3661.240
(e) Other Non-current assets	0.000	0.000	0.000
Total Non-Current Assets	122692.910	75050.750	76093.420
(2) Current assets
(a) Current investments	0.000	1627.900	1539.150
(b) Inventories	37593.250	31571.150	24704.120
(c) Trade receivables	31263.340	21396.870	22549.750
(d) Cash and bank balances	3837.440	1139.230	3183.850
(e) Short-term loans and advances	9601.030	8306.380	5365.500
(f) Other current assets	6075.530	9077.070	10457.550
Total Current Assets	88370.590	73118.600	67799.920
TOTAL	211063.500	148169.350	143893.340

PROFIT & LOSS ACCOUNT

	PARTICULARS	31.03.2016	31.03.2015	31.03.2014
	SALES
	Total Revenue from operations	94672.820	78571.570	69783.950
	Other Income	3499.840	4953.380	2495.730
	TOTAL	98172.660	83524.950	72279.680
Less	EXPENSES
	Cost of Materials Consumed	51030.800	43855.570	39270.100
	Purchases of Stock-in-Trade	506.140	574.120	972.540
	Changes in inventories of finished goods, work-in-progress and Stock-in-Trade	(4122.210)	(4586.190)	(3185.570)
	Employee benefit expense	8099.680	6452.050	4058.510
	Other expenses	26649.880	22350.570	16935.600
	Exceptional items before tax	0.000	0.000	(2983.770)
	TOTAL	82164.290	68646.120	55067.410
	PROFIT/ (LOSS) BEFORE INTEREST, TAX, DEPRECIATION AND AMORTISATION	16008.370	14878.830	17212.270
Less	FINANCIAL EXPENSES	7164.590	5686.310	2484.620
	PROFIT / (LOSS) BEFORE TAX, DEPRECIATION AND AMORTISATION	8843.780	9192.520	14727.650
Less	DEPRECIATION/ AMORTISATION	11908.010	8518.950	3461.790
	PROFIT/ (LOSS) BEFORE TAX	(3064.230)	673.570	11265.860
Less	TAX (H)	(1716.720)	(669.260)	2816.780
	PROFIT/ (LOSS) AFTER TAX	(1347.510)	1342.830	8449.080
	EARNINGS IN FOREIGN CURRENCY
	F.O.B. Value of Exports	79607.150	64964.530	55052.740
	Other Earning	3673.490	4114.310	4301.790
	TOTAL EARNINGS	83280.640	69078.840	59354.530
	IMPORTS
	Raw Materials	25622.620	23807.860	18136.720
	Chemicals/ Consumables	864.490	651.200	694.650
	Capital Goods	2281.360	1257.760	1110.590
	TOTAL IMPORTS	28768.470	25716.820	19941.960
	Earnings / (Loss) Per Share (INR)	(6.49)	7.09	33.02

CURRENT MATURITIES OF LONG TERM DEBT DETAILS

Particulars	31.03.2016	31.03.2015	31.03.2014
Current Maturities of Long term debt	3113.630	852.560	529.360
Net cash flows from (used in) operations	2805.100	7449.420	6733.470
Net cash flows from (used in) operating activities	2561.760	6791.590	3844.740

KEY RATIOS

EFFICIENCY RATIOS

PARTICULARS	31.03.2016	31.03.2015	31.03.2014
Average Collection Days (Sundry Debtors / Income * 365 Days)	120.53	99.40	117.94
Account Receivables Turnover (Income / Sundry Debtors)	3.03	3.67	3.09
Average Payment Days (Sundry Creditors / Purchases * 365 Days)	128.57	134.50	146.13
Inventory Turnover (Operating Income / Inventories)	0.43	0.47	0.70
Asset Turnover (Operating Income / Net Fixed Assets)	0.14	0.21	0.24

LEVERAGE RATIOS

PARTICULARS	31.03.2016	31.03.2015	31.03.2014
Debt Ratio ((Borrowing + Current Liabilities) / Total Assets)	0.66	0.65	0.68
Debt Equity Ratio (Total Liability / Networth)	1.60	1.48	1.59
Current Liabilities to Networth (Current Liabilities / Net Worth)	0.49	0.59	0.90
Fixed Assets to Networth (Net Fixed Assets / Networth)	1.70	1.47	1.73
Interest Coverage Ratio (PBIT / Financial Charges)	2.23	2.62	6.93

PROFITABILITY RATIOS

PARTICULARS		31.03.2016	31.03.2015	31.03.2014
PAT to Sales ((PAT / Sales) * 100)	%	(1.42)	1.71	12.11
Return on Total Assets ((PAT / Total Assets) * 100)	%	(0.64)	0.91	5.87
Return on Investment (ROI) ((PAT / Networth) * 100)	%	(1.97)	2.85	20.22

SOLVENCY RATIOS

PARTICULARS	31.03.2016	31.03.2015	31.03.2014
Current Ratio (Current Assets / Current Liabilities)	2.64	2.64	1.81
Quick Ratio ((Current Assets – Inventories) / Current Liabilities)	1.51	1.50	1.15
G-Score Ratio Financial (Networth / Total Assets)	0.32	0.32	0.29
G-Score Ratio Debt (Debts / Equity Capital)	224.83	184.22	179.34
G-Score Ratio Liquidity (Total Current Assets / Total Current Liabilities)	2.64	2.64	1.81

Total Liability = Short-term Debt + Long-term Debt + Current Maturities of Long-term debts

FINANCIAL ANALYSIS

[all figures are in INR Million]

DEBT EQUITY RATIO

Particular	31.03.2014	31.03.2015	31.03.2016
	INR In Million	INR In Million	INR In Million
Share Capital	369.510	378.560	487.030
Reserves & Surplus	41421.410	45010.120	67766.300
Share Application money pending allotment	0.000	1742.130	0.000
Net worth	41790.920	47130.810	68253.330
Long Term borrowings	60339.510	67782.740	101979.960
Short Term borrowings	5399.010	1102.410	4405.640
Current maturities of long term debt	529.360	852.560	3113.630
Total borrowings	66267.880	69737.710	109499.230
Debt/Equity ratio	1.586	1.480	1.604

YEAR-ON-YEAR GROWTH

Year on Year Growth	31.03.2014	31.03.2015	31.03.2016
	INR In Million	INR In Million	INR In Million
Sales	69783.950	78571.570	94672.820
		12.593	20.492

NET PROFIT MARGIN

Net Profit Margin	31.03.2014	31.03.2015	31.03.2016
	INR In Million	INR In Million	INR In Million
Sales	69783.950	78571.570	94672.820
Profit/(Loss)	8449.080	1342.830	(1347.510)
	12.11%	1.71%	(1.42%)

LEGAL CASES

HIGH COURT

SUN PARMA LABORATORIES LIMITED Vs. MYLAN LABORATORIES

High Court-Delhi

Case No:CS(COMM) 1098/2016 I.A. 21119/2014

Case Status:Pending

Judge:HON BLE MR. JUSTICE R.K.GAUBA

Date:2016-11-28

HIGH COURT

SRI J V PRASAD SC FOR INCOME TAX MS. MYLAN LABORATORIES LIMITED

High Court-Andhra Pradesh

Case No:ITTAMP 154/2016 ITTASR 138/2016

Case Status:Pending

Judge:HON BLE SRI JUSTICE SANJAY KUMAR HON BLE MRS JUSTICE ANIS

Date:2016-11-02

HIGH COURT

SRI J V PRASAD SC FOR INCOME TAX MS. MYLAN LABORATORIES LIMITED

High Court-Andhra Pradesh

Case No:ITTA 539/2016

Case Status:Pending

Judge:HON BLE SRI JUSTICE SANJAY KUMAR HON BLE MRS JUSTICE ANIS

Date:2016-11-09

HIGH COURT

SUN PARMA LABORATORIES LIMITED Vs. MYLAN LABORATORIES LIMITED AND ANR

High Court-Delhi

Case No:CS(OS) 3260/2014 I.A. 21119/2014 I.A. 11272/2015

Case Status:Pending

Judge:HON BLE MR. JUSTICE V. KAMESWAR RAO

Date:16-06-02

HIGH COURT

SUN PARMA LABORATORIES LIMITED Vs. MYLAN LABORATORIES LIMITED AND ANR

High Court-Delhi

Case No:CS(OS) 3260/2014 I.A. 21119/2014 I.A. 11272/2015

Case Status:Pending

Judge:HON BLE MS. JUSTICE HIMA KOHLI

Date:2016-08-10

HIGH COURT

SUN PARMA LABORATORIES LIMITED Vs. MYLAN LABORATORIES LIMITED AND ANR SINGH VISHNU REGE SAURABH KANSAL

High Court-Delhi

Case No:CS(COMM) 1098/2016 I.A. 21119/2014

Case Status:Pending

Judge:HON BLE MR. JUSTICE R.K.GAUBA

Date:2017-02-07

LOCAL AGENCY FURTHER INFORMATION

Sr. No.	Check list by info agents	Available in Report (Yes/No)
1	Year of establishment	Yes
2	Constitution of the entity -Incorporation details	Yes
3	Locality of the entity	Yes
4	Premises details	No
5	Buyer visit details	--
6	Contact numbers	Yes
7	Name of the person contacted	No
8	Designation of contact person	Yes
9	Promoter’s background	Yes
10	Date of Birth of Proprietor / Partners / Directors	Yes
11	Pan Card No. of Proprietor / Partners	Yes
12	Voter Id Card No. of Proprietor / Partners	No
13	Type of business	Yes
14	Line of Business	Yes
15	Export/import details (if applicable)	No
16	No. of employees	No
17	Details of sister concerns	Yes
18	Major suppliers	No
19	Major customers	No
20	Banking Details	Yes
21	Banking facility details	Yes
22	Conduct of the banking account	--
23	Financials, if provided	Yes
24	Capital in the business	Yes
25	Last accounts filed at ROC, if applicable	No
26	Turnover of firm for last three years	Yes
27	Reasons for variation <> 20%	--
28	Estimation for coming financial year	No
29	Profitability for last three years	Yes
30	Major shareholders, if available	Yes
31	External Agency Rating, if available	Yes
32	Litigations that the firm/promoter involved in	--
33	Market information	--
34	Payments terms	No
35	Negative Reporting by Auditors in the Annual Report	No

NOTE: Registered office of the company has been shifted from 1-1-151/1,Sairam Towers,4^th Floor, Alexander Road, Secunderabad – 500003, Telangana, India to the present address w.e.f. 15.03.2011

CORPORATE OVERVIEW

The company (formerly, Matrix Laboratories Limited), is engaged in the manufacture of Active Pharmaceutical Ingredients, Finished Dosage Formulations, Injectable and research and development activities. The Company is a subsidiary of MP Laboratories (Mauritius) Limited and the ultimate holding company is Mylan N.V., Netherlands. The Company has manufacturing locations spread across India.

REVIEW OF OPERATIONS

During the year, the turnover increased by 19% over the previous year. The increase in sales was mainly due to the increase in the sales of Active Pharmaceutical Ingredients (APIs) and Finished Dosage Form (FDF) products. The profit before interest, depreciation and tax for the year also showed a growth of 7.6 % over the previous year. The net loss was INR 1347.510 million as against the net profit of INR 1342.830 million over the previous year. The net loss was due to loss from injectable operations, amortization of goodwill / intangibles and interest on debentures.

During the year, the Company has raised funds through a mix of equity and debt by issue of 57601744 equity shares of INR 2/- each to Mylan Group B.V., and issue of 248034 Bonds, having a face value of INR 100000/- each to Mylan Luxembourg S.A.R.L., on private placement basis, for acquisition of the business of Jai Pharma Limited from Famy Care Limited.

The Company is in compliance with the regulations relating to downstream investment as laid down in the Foreign Exchange Management Regulations for the financial year 2015-2016 and the same is certified by the statutory auditors of the Company.

During the year there, the Company filed 12 US Drug Master Files (DMFs) and 7 EU DMFs / Certificates of Suitability to European Pharmacopoeia (CEPs) in Active pharmaceutical ingredient segment. With these filings, as on March 31, 2016, the cumulative number of DMFs filed by the Company, together with its subsidiaries and associates is 213 U.S. DMFs and 133 EU DMFs / CEPs.

During the year in Oral Solid Dosage segment, the Company has filed 10 ANDAs with the USFDA, 9 with European regulatory agencies, 2 with the WHO, 5 with Canada regulatory agencies, 9 with Japan PMDA, 7 with Australian regulatory agencies, 6 with New Zealand regulatory agencies and 13 with South Africa regulatory agencies. Aggregate filings covering Finished Dosage Forms during the year were 61 in number.

Cumulatively, the Company made the filings of 194 ANDAs with the USFDA, 133 regulatory filings with European regulatory agencies, 58 filings with the WHO, 77 with Canadian regulatory agencies, 71 with Australian regulatory agencies, 15 with Japan regulatory agencies, 47 with New Zealand, and 111 with South Africa regulatory agencies aggregating to 706 regulatory submissions. During the year their, the Company secured 14 approvals from the USA regulatory agencies, 3 approvals from the Australia regulatory agencies, 10 approvals from the Canada regulatory agencies, 12 approvals from the European regulatory agencies, 2 approvals from the Japan regulatory agencies, 1 approval from the New Zealand regulatory agencies, 3 approvals from the WHO regulatory agencies, and 1 from South Africa regulatory agencies.

In Injectable Segment, the Company has 90 approved ANDAs with the USFDA, 47 approved with Canada regulatory agencies and 18 with Africa regulatory agencies. Further, the Company has 115 pending for approval ANDAs with USFDA, 1 with Canada regulatory agencies and 63 with Africa regulatory agencies. Cumulatively, this segment has 334 regulatory submissions.

UNSECURED LOANS:

PARTICULARS	31.03.2016 INR In Million	31.03.2015 INR In Million
LONG-TERM BORROWINGS
Term loans from others	26896.490	0.000
Deferred payment liabilities	13.170	16.540
Debentures	0.000	50266.900
SHORT-TERM BORROWINGS
Loans repayable on demand	1416.980	477.430
Other loans and advances	2988.660	624.980
Total	31315.300	51385.850

INDEX OF CHARGES:

S No	SRN	Charge Id	Charge Holder Name	Date of Creation	Date of Modification	Date of Satisfaction	Amount	Address
1	C36138147	90128817	ANDHRA BANK	12/04/2005	06/07/2007	11/12/2014	186000000.0	R P. ROADSECUNDERABADSECUNDERABADAP500003IN
2	C15233083	10038930	HDFC BANK LIMITED	19/02/2007	20/03/2009	08/08/2014	450000000.0	HDFC BANK HOUSESENAPATI BAPAT MARGLOWER PAREL WMUMBAIMH400013IN
3	C14790752	10015348	ABN AMRO BANK	09/07/2006	20/03/2009	06/08/2014	450000000.0	6-3-24/1/1/A, ROAD NO. 1BANJARA HILLSHYDERABADAP500034IN
4	C14053219	10179307	INDUSIND BANK LTD.	21/07/2009	-	31/07/2014	300000000.0	2401 GEN THIMMAYYA ROADCONTONMENTPUNEMH411001IN
5	C14362313	10073046	BANK OF NOVA SCOTIA	21/09/2007	29/12/2008	30/07/2014	400000000.0	6-3-341/1, ROAD NO. 6BANJARA HILLSHYDERABADAP500034IN
6	C14362636	10155499	THE BANK OF NOVA SCOTIA	20/03/2009	-	30/07/2014	400000000.0	6-3-346/1, ROAD NO. 1BANJARA HILSHYDERABADAP500034IN
7	C13672852	90130616	HDFC BANK LIMITED	15/01/2005	08/06/2007	23/07/2014	434000000.0	HDFC BANK HOUSESENAPATI BAPAT MARGLOWER PAREL WMUMBAIMH400013IN
8	C13669296	90130372	HDFC BANK LIMITED	01/12/2003	-	23/07/2014	262500000.0	LAKDIKAPUL BRANCHSADEED PLAZAHYDERABADAPIN
9	C12053500	10198487	THE ROYAL BANK OF SCOTLAND N. V.	08/01/2010	29/07/2010	21/07/2014	470000000.0	74, SAKHAR BHAVAN,7TH FLOOR, NARIMAN POINT,MUMBAIMH400021IN
10	C12007159	10268093	DBS BANK LTD	27/01/2011	-	18/07/2014	480000000.0	SALARPURIA WINDSORNO.3, (OLD NO.10), ULSOOR ROAD, WARD NO. 78BANGALOREKA560042IN

CONTINGENT LIABILITIES:

PARTICULARS	31.03.2016 INR In Million	31.03.2015 INR In Million
Claims against company not acknowledged as debt	6254.300	6173.420
Other money for which company is contingently liable	165.820	151.570
Total	6420.120	6324.990

FIXED ASSETS:

Tangible Assets:

· Freehold land

· Buildings

· Plant and equipment

· Furniture and fixtures

· Vehicles

· Office equipment

· Computer hardware

· Electrical equipment

· Lab equipment

Intangible Asset:

· Computer software

PRESS RELEASE / WEBSITE DETAILS

DELHI HIGH COURT GIVES BIOCON, MYLAN GREEN LIGHT TO MARKET BLOCKBUSTER BIOSIMILAR FOR THREE CANCERS

NEW DELHI: The Delhi High Court has allowed Biocon and Mylan to sell their copies of Swiss giant Roche's blockbuster cancer drug ‘trastuzumab’ to treat three types of cancers, giving the biotech majors greater access to a INR 3000.000 Million potential market. 

According to an earlier court ruling, both companies could sell the drug to treat only one type of cancer and could not use the data of Roche’s own trastuzumab in package inserts for their brands ‘CANMab’ and ‘Hertraz’. 

The court’s latest move, which allows the companies to use Roche’s product data in their package inserts, is expected to allow Biocon and Mylan to grab more revenue in the cancer therapy market. 

A division bench comprising Justices Badar Durrez Ahmed and Sanjeev Sachdeva on Friday passed an interim order permitting Biocon and Mylan to sell their trastuzumab brands to treat metastatic breast cancer, early breast cancer and metastatic gastric cancer. So far, Biocon and Mylan were marketing their trastuzumab brands for only metastatic breast cancer. 

The order supersedes all previous interim orders on the issue, said the judges. They are expected to hear the case next on March 30. 

The court allowed Biocon and Mylan to market their products for the additional cancers based on approvals granted by the Drug Controller General of India (DCGI), India’s apex drug regulator, to manufacture, sell and market their brands as ‘biosimilar’ to Roche’s own trastuzumab brands. Government’s counsel Additional Solicitor General (ASG) Sanjay Jain told the court that DCGI had further approved package inserts that would allow the companies to sell CANMab and Hertraz to treat all three cancers.

A ‘biosimilar’ is a copy of a complex drug made of living cells. 

Roche, which invented trastuzumab, sells it under the brand names ‘Herclon’ and ‘Biceltis’ in India and as Herceptin globally. 

The judges also raised questions over Roche’s lawsuit against the companies and DCGI. 

The interim order was passed after counsels of Roche, Biocon and Mylan debated the use of Roche’s clinical trial data on the safety and efficacy of trastuzumab to treat early breast cancer and metastatic gastric cancer. Roche’s counsels argued that the data were being used by Biocon and Mylan to pass their own brands off as equally safe and effective without the companies doing their own clinical tests. 

Counsels for Biocon and Mylan, on the other hand, argued that the data used in the companies’ latest package insert were publicly available, and not exclusive to Roche. “The court has once again confirmed that there is no data exclusivity in India,” Pratibha Singh, counsel for Biocon, told ET. 

“This is a case that should have gone through the regulatory appellate board, and I hope this (order) sets a precedent for future such issues,” Biocon founder Kiran Mazumdar Shaw told ET. 

"We see this as a significant positive development which will pave the way fo greater access to affordable biosimilar trastuzumab for cancer patients in India," stated a company spokesperson. CANMab has been developed as per existing Indian biosimilar guidelines and was introduced in the market in 2014 after clinical studies and necessary regulatory approvals were obtained, the spokesperson added. 

Biocon’s share price on the Bombay Stock Exchange rose 3.76% to close at INR 1072.75 on Friday following the order. 

“Today’s decision means critical information about the clinical studies of our product Herceptin will be included on the packaging for these products, even though there continues to be no evidence in the public domain that the companies producing these products have conducted the studies required for biosimilars,” stated Roche in an official release following the order. “We believe it is important to ensure physicians and patients are not misled into believing these medicines will provide the same benefit and safety experience as our innovator medicine Herceptin.” 

Roche added that it would continue to challenge companies that fail to present data outlined in the Indian biosimilar framework. 

Mylan did not respond to ET’s emailed queries by the time this report went for publication.

Since 2014, Biocon and Mylan have been locked in a legal tussle against Roche over their approvals to sell copies of the Swiss company’s trastuzumab brands. 

The biotech majors had approached the Delhi High Court last year to appeal an April 25, 2016, order by Justice Manmohan Singh that ruled Biocon's CANMab and Mylan's Hertraz could not be called "biosimilar" or ascribe any biosimilarity to Herceptin, Herclon or Biceltis. 

The order had restrained the biosimilar makers from using data relating to the manufacturing process, safety, efficacy and tests until a final decision is made on the issue of their biosimilarity. 

The order had also called into question the processes followed by the Indian drug controller to approve the drugs as biosimilars. The division bench stayed this order on April 28, 2016. 

The appeal proceedings are still ongoing at the Delhi court. 

Apart from Biocon and Mylan, Reliance Life Sciences has also approached the court to appeal a similar order against their trastuzumab drug. This appeal is expected to be heard on March 30.

USFDA ACCEPTS MYLAN'S APPLICATION FOR PROPOSED BIOSIMILAR TRASTUZUMAB

NEW DELHI: Biotechnology major Biocon and pharma firm Mylan today said that the US health regulator has accepted Mylan's biologics license application (BLA) for MYL- 1401O, a proposed biosimilar trastuzumab indicated for treatment of breast cancer. 

The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the two companies said in a statement. 

Commenting on the development, Mylan President Rajiv Malik said: "The USFDA acceptance of our BLA for proposed biosimilar trastuzumab marks an important step toward increasing access to this treatment option for patients in the US." 

The company is committed to bringing this product to market and look forward to working with FDA over the next months, he added. 

This is Mylan and Biocon's "first US regulatory submission through the 351(k) pathway and reinforces the strength of our collaboration to increase access to a broad portfolio of high -quality, affordable biosimilars worldwide," Malik said. 

Mylan has exclusive commercialisation rights for the proposed biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries, the statement said. 

Biocon has co-exclusive commercialisation rights with Mylan for the product in the rest of the world, it added. 

"It is a major milestone for the Mylan and Biocon collaboration since it is the first US regulatory submission through our joint global biosimilars program," Biocon CEO and Joint Managing Director Arun Chandavarkar said. 

This development positions Biocon and Mylan among the first companies to be able to address the critical need of US patients for a high-quality biosimilar to treat certain HER2- positive breast cancers, in the near future, he added. 

Mylan and Biocon's proposed biosimilar trastuzumab is also under review by the European Medicines Agency (EMA), the statement said. 

The product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers, the companies said. 

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products.

USFDA ACCEPTS MYLAN'S BLA FOR PROPOSED BIOSIMILAR PEGFILGRASTIM

NEW DELHI: US health regulator USFDA has accepted pharma major Mylan's biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim, Biocon and Mylan have said. 

The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the two companies said in a statement.

Mylan President Rajiv Malik said: "This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months”.

The milestone builds on the acceptance of regulatory filings for proposed biosimilar Pegfilgrastim in Europe, Australia and Canada, he added. 

"Once approved, proposed biosimilar Pegfilgrastim will complement Mylan's broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer," Malik said. 

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is October 9, 2017, the statement said. 

"The FDA's acceptance for review of our second BLA for a proposed biosimilar developed by Biocon and Mylan is an outcome of our strong R&D and manufacturing capabilities," Biocon CEO and Joint MD Arun Chandavarkar said. 

Once approved, the proposed biosimilar Pegfilgrastim will provide a high quality alternative to branded Pegfilgrastim (Neulasta) for cancer patients during cytotoxic chemotherapy, he added. 

Mylan has exclusive commercialisation rights for the proposed biosimilar Pegfilgrastim in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries, the statement said. 

 Biocon has co-exclusive commercialisation rights with Mylan for the product in the rest of the world, it added. 

The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer. 

The stock of Biocon was today trading at INR 1106.90 in the afternoon trade on BSE, up 1.12 per cent from its previous close. 

LUPIN GETS FINAL USFDA NOD FOR MYLAN'S SKIN DISEASE CREAM

NEW DELHI: Pharma major LupinBSE -0.45 % today said it has received final approval from the US health regulator to market its generic version of Mylan's triamcinolone acetonide cream used for treatment of skin disease. 

The approval is for multiple strengths of 0.025 per cent, 0.1 per cent and 0.5 per cent triamcinolone acetonide cream which is used for relief from inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, the company said in a BSE filing. 

"Lupin shall commence promoting the product shortly," it added.

US FDA ACCEPTS BIOCON-MYLAN BIOSIMILAR APPLICATION FOR PROPOSED ANTI-CANCER BIO-SIMILAR

MUMBAI: Bangalore based Biocon announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s (Biocon’s partner for biosimilar development) Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta® (pegfilgrastim), an anti cancer drug. 

The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer. 

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Oct. 9, 2017. 

“We’re proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months”, said Rajiv Malik President Mylan. 

The milestone builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim in Europe, Australia, and Canada, once approved, proposed biosimilar pegfilgrastim will complement Mylan’s broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer, Malik added.

Biocon said that the FDA's acceptance for review of this biosimilar is an outcome of the company’s strong R&D and manufacturing capabilities.

CMT REPORT (Corruption, Money Laundering & Terrorism]

The Public Notice information has been collected from various sources including but not limited to: The Courts, India Prisons Service, Interpol, etc.

1] INFORMATION ON DESIGNATED PARTY

No records exist designating subject or any of its beneficial owners, controlling shareholders or senior officers as terrorist or terrorist organization or whom notice had been received that all financial transactions involving their assets have been blocked or convicted, found guilty or against whom a judgement or order had been entered in a proceedings for violating money-laundering, anti-corruption or bribery or international economic or anti-terrorism sanction laws or whose assets were seized, blocked, frozen or ordered forfeited for violation of money laundering or international anti-terrorism laws.

2] Court Declaration :

No records exist to suggest that subject is or was the subject of any formal or informal allegations, prosecutions or other official proceeding for making any prohibited payments or other improper payments to government officials for engaging in prohibited transactions or with designated parties.

3] Asset Declaration :

No records exist to suggest that the property or assets of the subject are derived from criminal conduct or a prohibited transaction.

4] Record on Financial Crime :

Charges or conviction registered against subject: None

5] Records on Violation of Anti-Corruption Laws :

Charges or investigation registered against subject: None

6] Records on Int’l Anti-Money Laundering Laws/Standards :

Charges or investigation registered against subject: None

7] Criminal Records

No available information exist that suggest that subject or any of its principals have been formally charged or convicted by a competent governmental authority for any financial crime or under any formal investigation by a competent government authority for any violation of anti-corruption laws or international anti-money laundering laws or standard.

8] Affiliation with Government :

No record exists to suggest that any director or indirect owners, controlling shareholders, director, officer or employee of the company is a government official or a family member or close business associate of a Government official.

9] Compensation Package :

Our market survey revealed that the amount of compensation sought by the subject is fair and reasonable and comparable to compensation paid to others for similar services.

10] Press Report :

No press reports / filings exists on the subject.

CORPORATE GOVERNANCE

MIRA INFORM as part of its Due Diligence do provide comments on Corporate Governance to identify management and governance. These factors often have been predictive and in some cases have created vulnerabilities to credit deterioration.

Our Governance Assessment focuses principally on the interactions between a company’s management, its Board of Directors, Shareholders and other financial stakeholders.

CONTRAVENTION

Subject is not known to have contravened any existing local laws, regulations or policies that prohibit, restrict or otherwise affect the terms and conditions that could be included in the agreement with the subject.

FOREIGN EXCHANGE RATES

Currency	Unit	INR
US Dollar	1	INR 65.22
UK Pound	1	INR 91.33
Euro	1	INR 79.96

INFORMATION DETAILS

Information Gathered by :	SVA
Analysis Done by :	PSD
Report Prepared by :	NKT

SCORE FACTORS

DEMERIT POINTS
--BANK CHARGES	YES/NO	YES
--LITIGATION	YES/NO	YES
--OTHER ADVERSE INFORMATION	YES/NO	NO
MERIT POINTS
--SOLE DISTRIBUTORSHIP	YES/NO	NO
--EXPORT ACTIVITIES	YES/NO	NO
--AFFILIATION	YES/NO	YES
--LISTED	YES/NO	NO
--OTHER MERIT FACTORS	YES/NO	YES

RATING EXPLANATIONS

Credit Rating	Explanation	Rating Comments
A++	Minimum Risk	Business dealings permissible with minimum risk of default
A+	Low Risk	Business dealings permissible with low risk of default
A	Acceptable Risk	Business dealings permissible with moderate risk of default
B	Medium Risk	Business dealings permissible on a regular monitoring basis
C	Medium High Risk	Business dealings permissible preferably on secured basis
D	High Risk	Business dealing not recommended or on secured terms only
NB	New Business	No recommendation can be done due to business in infancy stage
NT	No Trace	No recommendation can be done as the business is not traceable

NB is stated where there is insufficient information to facilitate rating. However, it is not to be considered as unfavourable.

This score serves as a reference to assess SC’s credit risk and to set the amount of credit to be extended. It is calculated from a composite of weighted scores obtained from each of the major sections of this report. The assessed factors are as follows:

· Financial condition covering various ratios

· Company background and operations size

· Promoters / Management background

· Payment record

· Litigation against the subject

· Industry scenario / competitor analysis

· Supplier / Customer / Banker review (wherever available)

PRIVATE & CONFIDENTIAL : This information is provided to you at your request, you having employed MIPL for such purpose. You will use the information as aid only in determining the propriety of giving credit and generally as an aid to your business and for no other purpose. You will hold the information in strict confidence, and shall not reveal it or make it known to the subject persons, firms or corporations or to any other. MIPL does not warrant the correctness of the information as you hold it free of any liability whatsoever. You will be liable to and indemnify MIPL for any loss, damage or expense, occasioned by your breach or non observance of any one, or more of these conditions

This report is issued at your request without any risk and responsibility on the part of MIRA INFORM PRIVATE LIMITED (MIPL) or its officials.