MIRA INFORM REPORT

 

 

Report Date :

03.05.2013

 

IDENTIFICATION DETAILS

 

Name :

AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

 

 

Registered Office :

882/1-871, Village Rajoda, Near Hotel Kankavati, Bavla, Ahmedabad  – 382 220, Gujarat

 

 

Country :

India

 

 

Financials (as on) :

31.03.2012

 

 

Date of Incorporation :

07.04.2006

 

 

Com. Reg. No.:

04-048109

 

 

Capital Investment / Paid-up Capital :

Rs.712.348 Millions

 

 

CIN No.:

[Company Identification No.]

U24231GJ2006PTC048109

 

 

TAN No.:

[Tax Deduction & Collection Account No.]

AHMA06911C

 

 

PAN No.:

[Permanent Account No.]

AAGCA0781K

 

 

Legal Form :

Private Limited Liability Company

 

 

Line of Business :

Subject is engaged in scientific research activities, including due diligence analytical testing for Abbreviated New Drug Application (ANDA) and marketing of research work and resulting products.

 

 

No. of Employees :

Not Available

 

 

RATING & COMMENTS

 

MIRA’s Rating :

B (35)

 

RATING

STATUS

 

PROPOSED CREDIT LINE

26-40

B

Capability to overcome financial difficulties seems comparatively below average.

Small

 

Maximum Credit Limit :

USD 2921000

 

 

Status :

Moderate

 

 

Payment Behaviour :

Slow but correct

 

 

Litigation :

Clear

 

 

Comments :

Subject is an established company having a moderate track record.

 

The company has been successful in wiping-off its accumulated losses of the previous year. Reserves of the company appear to be low.

 

Trade relations are reported as fair. Business is active. Payments are reported to be slow but correct.

 

The company can be considered for business dealings with some caution.

 

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 – June 30, 2012

 

Country Name

Previous Rating

(31.03.2012)

Current Rating

(30.06.2012)

India

A1

A1

 

Risk Category

ECGC Classification

Insignificant

 

A1

Low

 

A2

Moderate

 

B1

High

 

B2

Very High

 

C1

Restricted

 

C2

Off-credit

 

D

 

 

EXTERNAL AGENCY RATING

 

Rating Agency Name

ICRA

Rating

Term Loan: BBB-

Rating Explanation

Moderate degree of safety it carry moderate credit risk.

Date

October, 2012

 

 

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 31-03-2012.

 

LOCATIONS

 

Registered Office/ Research and Development Centre :

882/1-871, Village Rajoda, Near Hotel Kankavati, Bavla, Ahmedabad  – 382 220, Gujarat, India

Tel. No.:

91-2714-304700

Fax No. :

91-2714-304704

E-Mail :

accounts@amnealindia.com

India@amneal.com

vpindia@amneal.com

sales@amneal.com

Website :

www.amneal.com

Area :

3000 sq ft

Location :

Owned

 

 

New York Administrative Offices :

85 Adams Avenue, Hauppauge, New York 11788

Tel. No.:

631.952.0214

Fax No.:

631.656.1009

 

 

Account Management, Sales Operations and Customer Response Offices :

118 Beaver Trail, Glasgow, KY 42141

 

Tel. No.:

866.525.7270/ 270.678.9393

Fax No.:

866.525.7271

E-Mail :

sales@amneal.com

customerresponse@amneal.com

 

 

Business Development and Corporate Offices :

440 U.S. Highway 22 East, Suite 104, Bridgewater, NJ 08807

 

Tel. No.:

908.947.3120/ 908.947.3122

Fax No.:

908.947.4146

E-Mail :

businessdevelopment@amneal.com

 

 

DIRECTORS

 

As on 29.09.2012

 

Name :

Mr. Suresh Punambhai Patel

Designation :

Whole Time Director

Address :

Block No.54, Shri Somnath Nagar CHS Limited, Behind Sanghvi School, Navrangapura Road, Wadaj, Ahmedabad – 380 013, Gujarat, India

Date of Appointment :

01.10.2011

PAN No.:

ACRPP4822E

DIN No. :

01856345

Other Directorship :

 

S.No.

CIN/LLPIN

Name of the Company/ LLP

Current designation of the Director/ Designated Partner

Date of appointment at current designation

Original date of appointment

Date of cessation

Company/ LLP Status

Defaulting status

1

U24231GJ2006PTC048109

AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

Whole-time director

01/10/2011

07/04/2006

-

Active

NO

2

U73100GJ2008PTC053430

AMNEAL LIFE SCIENCES PRIVATE LIMITED

Director

31/03/2008

31/03/2008

-

Active

NO

3

U24233GJ2008PTC068526

RAKS PHARMA PRIVATE LIMITED

Director

30/09/2011

30/07/2010

-

Active

NO

 

 

Name :

Mr. Kanubhai Punambhai Patel

Designation :

Director

Address :

22, Ramyakunj Society, Galaxy Cinema, Naroda, Ahmedabad – 382 325, Gujarat, India

Date of Appointment :

17.11.2007

DIN No. :

01883090

Other Directorship :

 

S.No.

CIN/LLPIN

Name of the Company/ LLP

Current designation of the Director/ Designated Partner

Date of appointment at current designation

Original date of appointment

Date of cessation

Company/ LLP Status

Defaulting status

1

U24231GJ2006PTC048109

AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

Director

17/11/2007

17/11/2007

-

Active

NO

2

U73100GJ2008PTC053430

AMNEAL LIFE SCIENCES PRIVATE LIMITED

Director

31/03/2008

31/03/2008

-

Active

NO

 

 

Name :

Mr. Chintu Kanubhai Patel

Designation :

Director

Address :

115, Northfield Road., Parsippany, NJ 07054-3187, USA

Date of Appointment :

07.04.2006

DIN No. :

01980171

Other Directorship :

 

S.No.

CIN/LLPIN

Name of the Company/ LLP

Current designation of the Director/ Designated Partner

Date of appointment at current designation

Original date of appointment

Date of cessation

Company/ LLP Status

Defaulting status

1

U24231GJ2006PTC048109

AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

Director

07/04/2006

07/04/2006

-

Active

NO

2

U73100GJ2008PTC053430

AMNEAL LIFE SCIENCES PRIVATE LIMITED

Director

31/03/2008

31/03/2008

-

Active

NO

 

 

Name :

Mr. Nikunj Bansibhai Patel

Designation :

Whole Time Director

Address :

A/29/A, Karmachari Nagar Society, Part-1, Opposite Alkapuri Society, Ghatlodia, Ahmedabad – 380 061, Gujarat, India

Date of Birth/Age :

04.11.1975

Date of Appointment :

01.10.2011

PAN No.:

ALJPP2060M

DIN No. :

02790495

Other Directorship :

 

S.No.

CIN/LLPIN

Name of the Company/ LLP

Current designation of the Director/ Designated Partner

Date of appointment at current designation

Original date of appointment

Date of cessation

Company/ LLP Status

Defaulting status

1

U24231GJ2006PTC048109

AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

Whole-time director

01/10/2011

01/09/2009

-

Active

NO

2

U24233GJ2008PTC068526

RAKS PHARMA PRIVATE LIMITED

Director

30/09/2011

30/07/2010

-

Active

NO

 

 

KEY EXECUTIVES

 

Name :

Dr. Ravi Kumar Nithiyanandam

Designation :

Head Vice President (PR & D)

 

 

Name :

Dr. V.K. Agrawal

Designation :

Senior Vice President

 

 

Name :

Santhanakrishnan Srinivasan

Designation :

Director

 

 

Name :

Mr. Anil Kabra

Designation :

Senior General Manager (Finance)

 

 

Name :

Ms. Vanita Girdharilal Agrawal

Designation :

Secretary

Address :

14, Laxmi Society, Bed Mandir Road, Kankaria, Ahmedabad – 380 022, Gujarat, India

Date of Appointment :

02.02.2012

PAN No.:

AIAPA3799C

 

 

MAJOR SHAREHOLDERS / SHAREHOLDING PATTERN

 

As on 31.03.2012

 

Names of Shareholders

 

 

No. of Shares

Amneal Pharmaceuticals LLC, USA

 

57073229

Amneal Pharma Investment Holding, Mauritius

 

14011494

Nikunj Patel

 

150050

Suresh Patel

 

49

Suresh Patel C/o Rajchandra Medical Corporation, India

 

1

Total

 

71234823

 

As on 29.09.2012

 

Equity Share Breakup

 

Percentage of Holding

Category

 

 

Foreign holdings [Foreign institutional investors, Foreign Companies, Foreign Financial Institutions, Non-resident Indian or Overseas corporate bodies or others]

 

99.79

Directors or relatives of directors

 

0.21

Total

 

100.00

 

 

BUSINESS DETAILS

 

Line of Business :

Subject is engaged in scientific research activities, including due diligence analytical testing for Abbreviated New Drug Application (ANDA) and marketing of research work and resulting products.

 

 

GENERAL INFORMATION

 

No. of Employees :

Not Available

 

 

Bankers :

v  Bank of Baroda, S.G. Highway Branch, Shapath-III, Near GNFC Info Tower, S.G. Highway, Ahmedabad – 380 054, Gujarat, India

v  Bank of Baroda, Bank of Baroda Towers, 3rd Floor, Opposite Law Garden, Ellisbridge, Ahmedabad - 380 006, Gujarat, India

 

 

Facilities :

Secured Loans

31.03.2012

(Rs. in Millions)

31.03.2011

(Rs. in Millions)

LONG-TERM BORROWINGS

 

 

Rupee term loans from banks

271.596

143.068

Total

271.596

143.068

 

 

 

Banking Relations :

-

 

 

Auditors :

 

Name :

S.R. Batliboi and Associates

Chartered Accountants

Address :

2nd Floor, Shivalik, IshaanAhmedabad, Gujarat, India

PAN No. :

AABFS3421N

 

 

Holding Company :

Amneal Pharmaceuticals LLC, USA

 

 

Fellow Subsidiary Company :

Amneal Pharma Investment Holdings, Mauritius

 

 

Enterprises which are owned, or have significant influence of or are partners with Key management personnel and their relatives :

  • Amneal Life Sciences Private Limited, India (CIN No.: U73100GJ2008PTC053430)
  • Rajchandra Medical Corporation, India
  • Raks Pharma Private Limited, India (CIN No.: U24233GJ2008PTC068526)

 

 

CAPITAL STRUCTURE

 

As on 31.03.2012

 

Authorised Capital :

No. of Shares

Type

Value

Amount

75000000

Equity Shares

Rs.10/- each

Rs.750.000 Millions

 

 

 

 

 

Issued, Subscribed & Paid-up Capital :

No. of Shares

Type

Value

Amount

71234823

Equity Shares

Rs.10/- each

Rs.712.348 Millions

 

 

 

 

 

 


 

FINANCIAL DATA

[all figures are in Rupees Millions]

 

ABRIDGED BALANCE SHEET

 

SOURCES OF FUNDS

 

31.03.2012

31.03.2011

31.03.2010

SHAREHOLDERS FUNDS

 

 

 

1] Share Capital

712.348

572.233

415.324

2] Share Application Money

0.000

0.000

0.000

3] Reserves & Surplus

17.791

0.000

0.000

4] (Accumulated Losses)

0.000

(3.910)

(22.103)

NETWORTH

730.139

568.323

393.221

LOAN FUNDS

 

 

 

1] Secured Loans

271.596

143.068

127.580

2] Unsecured Loans

127.900

0.000

1.778

TOTAL BORROWING

399.496

143.068

129.358

DEFERRED TAX LIABILITIES

4.759

5.815

3.745

 

 

 

 

TOTAL

1134.394

717.206

526.324

 

 

 

 

APPLICATION OF FUNDS

 

 

 

 

 

 

 

FIXED ASSETS [Net Block]

362.309

356.557

327.102

Capital work-in-progress

445.875

95.999

7.149

 

 

 

 

INVESTMENT

81.502

0.000

0.000

DEFERRED TAX ASSETS

0.000

0.000

0.000

 

 

 

 

CURRENT ASSETS, LOANS & ADVANCES

 

 

 

 

Inventories

67.813
45.922
17.354

 

Sundry Debtors

121.179
0.000
0.000

 

Cash & Bank Balances

125.074
41.202
4.792

 

Other Current Assets

9.004
6.663
6.647

 

Loans & Advances

80.533
290.576
253.658

Total Current Assets

403.603
384.363
282.451

Less : CURRENT LIABILITIES & PROVISIONS

 

 

 

 

Sundry Creditors

3.421

1.185

29.005

 

Other Current Liabilities

143.801
107.506
60.002

 

Provisions

11.673
11.022
1.371

Total Current Liabilities

158.895
119.713
90.378

Net Current Assets

244.708
264.650
192.073

 

 

 

 

MISCELLANEOUS EXPENSES

0.000

0.000

0.000

 

 

 

 

TOTAL

1134.394

717.206

526.324

 

 

 

 

PROFIT & LOSS ACCOUNT

 

 

PARTICULARS

31.03.2012

31.03.2011

31.03.2010

 

SALES

 

 

 

 

 

Income

408.890

256.021

118.886

 

 

Other Income

6.755

1.215

13.908

 

 

TOTAL                                     (A)

415.645

257.236

132.794

 

 

 

 

 

Less

EXPENSES

 

 

 

Personnel Expenses

382.090

229.474

33.515

 

 

Operating and Administrative Expenses

 

 

47.948

 

 

Exceptional items

 

 

26.229

 

 

Prop period items

 

 

0.000

 

 

TOTAL                                     (B)

382.090

(including financial & depreciation)

229.474

(including financial & depreciation)

107.692

 

 

 

 

 

Less

PROFIT/ (LOSS) BEFORE INTEREST, TAX, DEPRECIATION AND AMORTISATION (A-B)     (C)

 

 

25.102

 

 

 

 

 

Less

FINANCIAL EXPENSES                                    (D)

 

 

17.202

 

 

 

 

 

 

PROFIT/ (LOSS) BEFORE TAX, DEPRECIATION AND AMORTISATION (C-D)                               (E)

 

 

7.900

 

 

 

 

 

Less/ Add

DEPRECIATION/ AMORTISATION                     (F)

 

 

21.677

 

 

 

 

 

 

PROFIT/ (LOSS) BEFORE TAX (E-F)                 (G)

33.555

27.762

(13.777)

 

 

 

 

 

Less

TAX                                                                  (H)

11.854

9.570

1.626

 

 

 

 

 

 

PROFIT/ (LOSS) AFTER TAX (G-H)                   (I)

21.701

18.192

(15.403)

 

 

 

 

 

Add

PREVIOUS YEARS’ BALANCE BROUGHT FORWARD

NA

(22.102)

(6.699)

 

 

 

 

 

 

BALANCE CARRIED TO THE B/S

NA

NA

(22.102)

 

 

 

 

 

 

EARNINGS IN FOREIGN CURRENCY

 

 

 

 

 

Rendering of contract research and development services

NA

256.021

118.886

 

TOTAL EARNINGS

NA

256.021

118.886

 

 

 

 

 

 

IMPORTS

 

 

 

 

 

Capital Goods

29.908

39.212

16.674

 

 

Raw Materials

2.347

0.749

 

 

 

Consumables

0.462

0.139

 

 

TOTAL IMPORTS

32.717

40.100

16.674

 

 

 

 

 

 

Earnings/ (Loss) Per Share (Rs.)

0.37

0.40

(0.69)

 

KEY RATIOS

 

PARTICULARS

 

 

31.03.2012

31.03.2011

31.03.2010

PAT / Total Income

(%)

5.22

7.07

(11.60)

 

 

 

 

 

Net Profit Margin

(PBT/Sales)

(%)

8.21

10.84

(11.59)

 

 

 

 

 

Return on Total Assets

(PBT/Total Assets}

(%)

4.38

3.75

(2.26)

 

 

 

 

 

Return on Investment (ROI)

(PBT/Networth)

 

0.05

0.05

(0.04)

 

 

 

 

 

Debt Equity Ratio

(Total Debt/Networth)

 

0.55

0.25

0.33

 

 

 

 

 

Current Ratio

(Current Asset/Current Liability)

 

2.54

3.21

3.13

 

 

LOCAL AGENCY FURTHER INFORMATION

 

Check List by Info Agents

Available in Report (Yes / No)

1) Year of Establishment

Yes

2) Locality of the firm

Yes

3) Constitutions of the firm

Yes

4) Premises details

Yes

5) Type of Business

Yes

6) Line of Business

Yes

7) Promoter’s background

Yes

8) No. of employees

No

9) Name of person contacted

No

10) Designation of contact person

No

11) Turnover of firm for last three years

Yes

12) Profitability for last three years

Yes

13) Reasons for variation <> 20%

--

14) Estimation for coming financial year

No

15) Capital in the business

Yes

16) Details of sister concerns

Yes

17) Major suppliers

No

18) Major customers

No

19) Payments terms

No

20) Export / Import details (if applicable)

No

21) Market information

--

22) Litigations that the firm / promoter involved in

--

23) Banking Details

Yes

24) Banking facility details

Yes

25) Conduct of the banking account

--

26) Buyer visit details

--

27) Financials, if provided

Yes

28) Incorporation details, if applicable

Yes

29) Last accounts filed at ROC

Yes

30) Major Shareholders, if available

Yes

31) Date of Birth of Proprietor/Partner/Director, if available

Yes

32) PAN of Proprietor/Partner/Director, if available

Yes

33) Voter ID No of Proprietor/Partner/Director, if available

No

34) External Agency Rating, if available

Yes

 

 


 

Unsecured Loans

31.03.2012

(Rs. in Millions)

31.03.2011

(Rs. in Millions)

LONG-TERM BORROWINGS

 

 

Foreign currency term loans from others

127.900

0.000

Total

127.900

0.000

 

Note:

The registered office of the company has been shifted from 9, Indus Park Society, Opposite Sundervan, Near Spipa, Ahmedabad, Gujarat to the present address w.e.f. 01.07.2009.

 

CORPORATE INFORMATION:

 

The company, domiciled in India and incorporated under the provisions of the Companies Act, 1956 is engaged in scientific research activities, including due diligence analytical testing for Abbreviated New Drug Application (ANDA) and marketing of research work and resulting products, if any, mainly for exports to its parent company, Amneal Pharmaceuticals LLC, USA.

 

PERFORMANCE REVIEW:

 

During the year the company has further strengthened its’ business and its Sales of Services of the Company at Rs.408.890 millions.

 

SHARE CAPITAL:

 

During the year authorized Capital is increased to Rs.750.000 millions and the paid up capital of the company has been increased to Rs.712.348 millions.

 

Bankers Charges Report as per Registry

 

Corporate identity number of the company

U24231GJ2006PTC048109

Name of the company

AMNEAL PHARMACEUTICALS COMPANY (INDIA) PRIVATE LIMITED

Address of the registered office or of the principal place of  business in India of the company

882/1-871, Village Rajoda, Near Hotel Kankavati, Bavla, Ahmedabad  – 382 220, Gujarat, India

E-Mail: accounts@amnealindia.com

This form is for

Creation of charge

Type of charge

Movable Property (not being pledge)

Others (Vehicle)

Particular of charge holder

Bank of Baroda, S.G. Highway Branch, Shapath-III, Near GNFC Info Tower, S.G. Highway, Ahmedabad – 380 054, Gujarat, India

E-Mail: rm.ahmedabadcity@bankofbaroda.com

Nature of description of the instrument creating or modifying the charge

Instrument of Hypothecation of Vehicle

Date of instrument Creating the charge

11.12.2012

Amount secured by the charge

Rs.0.799 million

Brief particulars of the principal terms an conditions and extent and operation of the charge

Rate of Interest:

1.75% above base rate i.e. 12.25% at monthly rest

 

Terms of Repayment:

60 monthly installments of Rs.0.013 million each such installments being payable on  Schedule B here under written the first of such installment being payable on the 11th day of December and subsequent installment being payable on the 11th day of each succeeding month

 

Margin:

10%

 

Extent and Operation of the charge:

First Charge over the Mahindra Xylo D2 Silver 75F

Short particulars of the property charged

Mahindra Xylo D2 Silver 75F

 

 

FIXED ASSETS:

 

v  Freehold Land

v  Buildings

v  Plant and Machinery

v  Furniture and Fixtures

v  Vehicles

v  Office Equipment

v  Computer

v  Electrical Equipments and Fitting

v  Computer Software

 

PRESS RELEASES:

 

AMNEAL PHARMACEUTICALS RECEIVES FDA APPROVAL FOR GENERIC SUBOXONE®

 

Buprenorphine HCl and Naloxone HCl tablets for treating opioid addiction expected to save millions in healthcare costs

 

Bridgewater, NJ (USA), February 25, 2013

 

Amneal Pharmaceuticals, LLC, the 7th largest generic drug manufacturer in the U.S. market, has received U.S. FDA approval for one of the first generic versions of Suboxone® sublingual tablets for maintenance treatment of opioid drug dependence. Generic buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets are now available in 2 mg/0.5 mg and 8 mg/2 mg strengths, both in 30-count bottles. The Amneal medication is bioequivalent to Suboxone® (a registered trademark of Reckitt Benckiser Healthcare (UK) Limited (RB.L)). Annual U.S. sales of Suboxone® in all dosage forms are $1.5 billion, according to December 2012 IMS Health market data.

 

Providing opioid-dependent patients with high quality generic buprenorphine HCl and naloxone HCl through treatment in physicians’ offices, treatment centers, or prescriptions filled at retail pharmacies offers tremendous cost savings for both consumers and the U.S. healthcare system, while delivering the same therapeutic effect as the brand medication. To help their patients take advantage of this lower cost alternative, physicians should clearly indicate “buprenorphine HCl and naloxone HCl tablets” or “Suboxone® tablets” when writing prescriptions to avoid confusion at the pharmacy. Patients currently using any form of Suboxone® should ask their doctors or dispensing pharmacists for buprenorphine HCl and naloxone HCl sublingual tablets to get the cost-saving generic version with a pleasant orange flavor.

 

In addition to patients and their prescribing physicians, a more cost-effective opioid addiction treatment should be welcome news to insurance companies, the Centers for Medicare and Medicaid Services, the Veterans Health Administration and other payors, pharmacy benefits managers (PBMs), managed care facilities, drug addiction and recovery organizations and treatment advocacy groups as well. Generic drugs are saving the U.S. healthcare system one billion dollars every other day, according to the Generic Pharmaceutical Association.

 

“The FDA’s decision to approve the first generic equivalents to Suboxone® sublingual tablets will ensure that millions of patients in the U.S. who need this product now have access to a high quality, low cost generic version,” said Chirag Patel, President and Co-Chairman of Amneal. “Since the agency has issued its opinion on Reckitt Benckiser’s September 2012 Citizen’s Petition in favor of generic competition, Amneal’s buprenorphine HCl and naloxone HCl tablets can offer consumers and physicians greater choice in opioid addiction treatment. We are also pleased that the FDA has referred this matter to the Federal Trade Commission to investigate and address Reckitt’s anticompetitive business practices.”

 

“We appreciate the FDA’s thorough assessment of Reckitt’s Citizen’s Petition and applaud their recent decision to deny it in its entirety,” said Chintu Patel, Amneal CEO and Co-Chairman. “The FDA determined that Reckitt’s petition did not raise valid scientific or regulatory issues associated with the product, which Amneal contended in its comments on the petition. Physicians should have no concerns in writing prescriptions for the generic tablet form of the product.”

 

Manufactured in Amneal’s fully FDA-compliant Brookhaven, NY facility, buprenorphine HCl and naloxone HCl tablets will be available through wholesalers and distributors as well as directly to the trade. The product received FDA approval under an approved Risk Evaluation and Mitigation Strategy (REMS), known as the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS program, and will be distributed in accordance with FDA and U.S. Drug Enforcement Administration (DEA) regulations governing the handling of CIII controlled substances. The generic tablets will be available to patients when the BTOD REMS program becomes operational in early March.

 

Amneal Pharmaceuticals, LLC is a U.S.-based manufacturer of generic pharmaceuticals. Known as “Generic’s New Generation,” Amneal prides itself on its unwavering commitment to quality, meaningful business relationships, and innovative approach to maximizing value for all stakeholders. Extensive investment in R&D, an intelligently aggressive expansion strategy, and focus on vertical integration are key contributors to the company’s impressive growth over the past several years. Amneal is headquartered in Bridgewater, New Jersey with manufacturing, R&D, packaging, sales and distribution facilities throughout the U.S., as well as abroad.

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AMNEAL PARTNERS WITH HANMI TO MARKET NEXIUM® ALTERNATIVE

 

January 28, 2013 

 

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, LLC today announced that it has entered into a license and distribution agreement with South Korea-based Hanmi Pharmaceutical Co., Limited to acquire exclusive distribution rights to Hanmi's new drug application (NDA), currently under FDA review, for esomeprazole strontium delayed-release capsules. Hanmi’s NDA was filed with the U.S. FDA pursuant to Section 505(b)(2) of the Food, Drug and Cosmetic Act including comparative bioequivalence testing against AstraZeneca's Nexium® (esomeprazole magnesium delayed-release capsules). Originally submitted to the FDA in October 2010 with additional development data subsequently provided by Hanmi, the NDA has been granted a revised Prescription Drug User Fee Act (PDUFA) date of April 29, 2013.

 

“We are very excited to enter into this partnership with Hanmi, as it gives Amneal the opportunity to introduce a high quality, low cost esomeprazole strontium product into the U.S. market, potentially before other generic competitors”

 

“We are very excited to enter into this partnership with Hanmi, as it gives Amneal the opportunity to introduce a high quality, low cost esomeprazole strontium product into the U.S. market, potentially before other generic competitors,” said Chirag Patel, President of Amneal. Amneal expects the product to obtain timely FDA approval, and subject to the favorable resolution of ongoing litigation between Hanmi and AstraZeneca, Amneal anticipates a potential commercial launch in 2013, prior to the expected entry of generic versions of Nexium®.

 

About Amneal Pharmaceuticals, LLC

Amneal Pharmaceuticals, LLC is a U.S.-based manufacturer of generic pharmaceuticals. Known as “Generic’s New Generation,” Amneal prides itself on its unwavering commitment to quality, meaningful business relationships, and innovative approach to maximizing value for all stakeholders. Extensive investment in R&D, an intelligently aggressive expansion strategy, and focus on vertical integration are key contributors to the company’s impressive growth over the past several years. Amneal is headquartered in Bridgewater, New Jersey with manufacturing, R&D, packaging, sales and distribution facilities throughout the U.S., as well as abroad.

 


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 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 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

Indian Rupees

US Dollar

1

Rs.53.74

UK Pound

1

Rs.83.54

Euro

1

Rs.70.72  

 

 

INFORMATION DETAILS

 

Report Prepared by :

SMN

 


 

SCORE & RATING EXPLANATIONS

 

SCORE FACTORS

 

RANGE

POINTS

HISTORY

1~10

4

PAID-UP CAPITAL

1~10

5

OPERATING SCALE

1~10

3

FINANCIAL CONDITION

 

 

--BUSINESS SCALE

1~10

5

--PROFITABILIRY

1~10

4

--LIQUIDITY

1~10

4

--LEVERAGE

1~10

4

--RESERVES

1~10

3

--CREDIT LINES

1~10

3

--MARGINS

-5~5

-

DEMERIT POINTS

 

 

--BANK CHARGES

YES/NO

YES

--LITIGATION

YES/NO

NO

--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

DEFAULTER

 

 

--RBI

YES/NO

NO

--EPF

YES/NO

NO

TOTAL

 

35

 

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 and their relative weights (as indicated through %) are as follows:

 

Financial condition (40%)            Ownership background (20%)                  Payment record (10%)

Credit history (10%)                   Market trend (10%)                                Operational size (10%)

 


 

RATING EXPLANATIONS

 

 

RATING

STATUS

 

 

PROPOSED CREDIT LINE

>86

Aaa

Possesses an extremely sound financial base with the strongest capability for timely payment of interest and principal sums

 

Unlimited

71-85

Aa

Possesses adequate working capital. No caution needed for credit transaction. It has above average (strong) capability for payment of interest and principal sums

 

Large

56-70

A

Financial & operational base are regarded healthy. General unfavourable factors will not cause fatal effect. Satisfactory capability for payment of interest and principal sums

 

Fairly Large

41-55

Ba

Overall operation is considered normal. Capable to meet normal commitments.

 

Satisfactory

26-40

B

Capability to overcome financial difficulties seems comparatively below average.

 

Small

11-25

Ca

Adverse factors are apparent. Repayment of interest and principal sums in default or expected to be in default upon maturity

 

Limited with full security

<10

C

Absolute credit risk exists. Caution needed to be exercised

 

 

Credit not recommended

-

NB

                                       New Business

-

 

 

 

 

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.