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Corporate Comprehensive Compliance Program (CCP) Statement

Cadista Pharmaceuticals Inc. is committed to conducting business in an ethical manner and complying with State and Federal pharmaceutical compliance program guidelines. Our Comprehensive Compliance Program (CCP) is in accordance with guidelines established by the Office of Inspector General of the United States Department of Health and Human Services (OIG HHS) and the Pharmaceutical Research and Manufacturer’s Association (PhRMA). Our CCP is also in accordance to recent regulations and State Bills (SB’s) that establish annual spending limits on promotional marketing materials and on items or gifts given to healthcare providers (e.g., California State Bill (SB 1765), effective July 1, 2005). A declaration of compliance with the law is published on an annual basis.

Our Comprehensive Compliance Program includes the following, but is not limited to:

Policies, procedures and protocols that are written and revised as needed. These practices guide Cadista Pharmaceuticals Inc. and the conduct of our employees in our day-to-day operations.

A Formal Corporate Compliance Program that includes a corporate compliance committee and a full-time compliance officer who has the authority to report significant issues directly to the CEO and to the Board of Directors. The Compliance Officer is a senior executive staff member who is responsible for developing, implementing, operating and monitoring the compliance program.

A communication plan has been developed which includes a hotline, 410-912-3768, accessible 24-hours a day, seven days a week, and an email mailbox, cadista_us_compliance@jubl.com, to field complaints and concerns from employees or others. Calls can be made anonymously and without fear of retribution. Reports of compliance violations may also be faxed to 410-860-8719.

Investigation of all suspected non-compliance offenses will be documented, reported and prompt corrective action taken as warranted.

A Code of Employee Conduct that articulates Cadista Pharmaceuticals Inc.’s expectations of commitment to compliance by management, employees and agents.

Effective, ongoing training, education and certification programs for our employees regarding the Corporate Compliance Program.

Internal monitoring and auditing of our compliance program and marketing practices on a routine basis to detect and prevent deviations from the CCP.

Enforcement of standards with well-publicized disciplinary guidelines.

Cadista Pharmaceuticals Inc. Marketing Practices

Cadista Pharmaceuticals Inc. maintains its dedication to providing healthcare providers with the best possible products and services. To that end, we have established Sales and Marketing practices that will deliver valuable information to healthcare professionals and further enhance their knowledge of current health and treatment options for their patients.

Because compliance is a dynamic and changing process, we regularly assess and monitor our response to recent legislation and modify our Marketing program guidelines accordingly, while maintaining the highest service standard that meets our customer’s needs and expectations.
Cadista Pharmaceuticals Inc. has set the following annual spending limits (maximum amount) to a cumulative annual dollar limit of $2,000.00 per Medical and Healthcare Professional. Cadista Pharmaceuticals Inc. reserves the right to revise this limit. The annual spending limit includes following example items:

The value of gifts and promotional materials, including modest meals and activities that are provided by Cadista Pharmaceuticals Inc. to healthcare professionals in connection with the promotion of our products.

Medically-relevant items such as: Physician desk reference books and medical textbooks provided to the physician primarily for the benefit of the patient.

Meals, receptions, etc., that are provided in connection with Cadista Pharmaceuticals Inc.’s efforts to advance the healthcare professional’s knowledge in regard to the safety, efficacy and benefits of Cadista Pharmaceuticals Inc.’s line of products.

Cadista Pharmaceuticals Inc. excludes the following items from the annual spending limit listed above, consistent with our understanding of similar pharmaceutical marketing laws (e.g., Maine, California, Vermont, D.C.). Cadista Pharmaceuticals Inc.’s annual spending limit does not include:

Samples provided to physicians and healthcare providers intended for free distribution and benefit for their patients.

Reminder items of small monetary value (under $25.00) such as pens, paper pads and calendars.

Financial support for independent education, health education scholarships and medical education conferences.

Payment for professional services including, but not limited to, professional speakers, advisors, consultants, market research and independent training services, that are based on the fair market value of the services provided.

Miscellaneous items such as diaries, physician and patient educational materials that are provided to the healthcare professional with the purpose of enhancing the patient’s knowledge of the disease state, disorder and treatment directions.

Compliance Declaration
For the period from July 1, 2006 through June 30, 2007, Cadista Pharmaceuticals Inc. asserts to the best of our knowledge and in all material respects, and based upon a good faith understanding of applicable statutory requirements, that we are in compliance with our Comprehensive Compliance guidelines established in 2005. We recognize that compliance is a dynamic concept that must be adapted to the specific characteristics of the individual company. With this in mind, the guidelines established are in effect, and compliance is monitored regularly to prevent and detect misconduct. Cadista Pharmaceuticals Inc.'s Corporate Compliance Program (CCP) will be reassessed at least annually, and may be modified periodically, to enhance program effectiveness and to better address, detect and prevent any impropriety.

To obtain a printed copy of Cadista Pharmaceuticals Inc.'s statement of compliance or our Corporate Compliance Program, please call us at 410-912-3768.

Corporate Comprehensive Compliance Program (CCP) Statement

Our Comprehensive Compliance Program includes the following, but is not limited to:

Policies, procedures and protocols that are written and revised as needed. These practices guide Cadista Pharmaceuticals Inc. and the conduct of our employees in our day-to-day operations.

Investigation of all suspected non-compliance offenses will be documented, reported and prompt corrective action taken as warranted.

A Code of Employee Conduct that articulates Cadista Pharmaceuticals Inc.’s expectations of commitment to compliance by management, employees and agents.

Effective, ongoing training, education and certification programs for our employees regarding the Corporate Compliance Program.

Internal monitoring and auditing of our compliance program and marketing practices on a routine basis to detect and prevent deviations from the CCP.

Enforcement of standards with well-publicized disciplinary guidelines.

Cadista Pharmaceuticals Inc. Marketing Practices

The value of gifts and promotional materials, including modest meals and activities that are provided by Cadista Pharmaceuticals Inc. to healthcare professionals in connection with the promotion of our products.

Medically-relevant items such as: Physician desk reference books and medical textbooks provided to the physician primarily for the benefit of the patient.

Meals, receptions, etc., that are provided in connection with Cadista Pharmaceuticals Inc.’s efforts to advance the healthcare professional’s knowledge in regard to the safety, efficacy and benefits of Cadista Pharmaceuticals Inc.’s line of products.

Cadista Pharmaceuticals Inc. excludes the following items from the annual spending limit listed above, consistent with our understanding of similar pharmaceutical marketing laws (e.g., Maine, California, Vermont, D.C.). Cadista Pharmaceuticals Inc.’s annual spending limit does not include:

Samples provided to physicians and healthcare providers intended for free distribution and benefit for their patients.

Reminder items of small monetary value (under $25.00) such as pens, paper pads and calendars.

Financial support for independent education, health education scholarships and medical education conferences.

Payment for professional services including, but not limited to, professional speakers, advisors, consultants, market research and independent training services, that are based on the fair market value of the services provided.

Miscellaneous items such as diaries, physician and patient educational materials that are provided to the healthcare professional with the purpose of enhancing the patient’s knowledge of the disease state, disorder and treatment directions.

To obtain a printed copy of Cadista Pharmaceuticals Inc.'s statement of compliance or our Corporate Compliance Program, please call us at 410-912-3768.