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Last C$3.72 CAD
Change Today +0.07 / 1.92%
Volume 2.8K
As of 3:44 PM 07/3/15 All times are local (Market data is delayed by at least 15 minutes).

intellipharmaceutics interna (I) Snapshot

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52 Week High
05/26/15 - C$4.86
52 Week Low
08/27/14 - C$2.14
Market Cap
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Dividend Yield

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intellipharmaceutics interna (I) Details

Intellipharmaceutics International Inc., a pharmaceutical company, engages in the research, development, and manufacture of novel and generic controlled and targeted release oral solid dosage drugs in Canada. The company develops various drug delivery systems and a pipeline of products based on its patented Hypermatrix technology in various stages of development in therapeutic areas, such as neurology, cardiovascular, gastrointestinal tract, diabetes, and pain. Its products under abbreviated new drug application stage include Focalin XR, a dexmethylphenidate hydrochloride extended-release capsule for hyperactivity disorders; Effexor XR, a venlafaxine hydrochloride extended-release capsule for depression; Protonix, a tablet for gastroesophageal reflux diseases; Glucophage XR, a tablet for managing type 2 diabetes; Seroquel XR, a tablet for the treatment of schizophrenia, as well as bipolar and depressive disorders; Lamictal XR, a tablet for anti-convulsant for epilepsy; Keppra XR, a tablet for the treatment of partial onset seizures for epilepsy; and Pristiq, a tablet for depression. The company is also developing Oleptro, a trazodone hydrochloride extended release tablet for treating depression; Coreg CR, a capsule, which is in late-stage development for heart failure and hypertension; OxyContin, a controlled release capsule that is in phase I clinical trial for pain; and Lyrica, a capsule, which is in phase I clinical trial for neuropathic pain. Its non-generic products under development include Rexista, an oral formulation for pain relief; and Regabati XR, a pregabalin extended release capsule that has completed an initial phase I clinical trial for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury, and fibromyalgia. The company has a license and commercialization agreement with Par Pharmaceutical, Inc. Intellipharmaceutics International Inc. is headquartered in Toronto, Canada.

46 Employees
Last Reported Date: 02/27/15

intellipharmaceutics interna (I) Top Compensated Officers

Co-Founder, Chairman, Chief Executive Officer...
Total Annual Compensation: $582.0K
President, Chief Operating Officer and Direct...
Total Annual Compensation: $582.0K
Chief Financial Officer
Total Annual Compensation: $5.2K
Vice President of Legal Affairs & Licensing, ...
Total Annual Compensation: $132.2K
Compensation as of Fiscal Year 2014.

intellipharmaceutics interna (I) Key Developments

Intellipharmaceutics International Inc. Updates Status of Tentative Approvals of Generic Focalin XR(R)

Intellipharmaceutics International Inc. announced that the United States Food and Drug Administration (FDA) has indicated that the Company's tentatively-approved strengths of its generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules will have to meet newly-imposed conditions for bioequivalence prior to receiving final approval. The strengths affected are 5 mg, 10 mg, 20 mg and 40 mg. The already-approved 15 mg and 30 mg strengths now in the market are not affected. The FDA, in November 2013, had previously granted the Company tentative approvals for the 5 mg, 10 mg, 20 mg, and 40 mg strengths of its generic Focalin XR®. The Company is now required by the FDA to demonstrate bioequivalence with Focalin XR®, under the new bioequivalence criteria, for the 40 mg strength as a basis for the approval of each of the affected strengths. The Company, together with its United States commercialization partner, Par Pharmaceutical Inc., intends to review and vigorously pursue all reasonable courses of action towards achieving final approval for each of the affected strengths. There can be no assurance that the affected strengths of the Product will be granted final FDA approval or sold commercially.

FDA Grants Fast Track Designation for Intellipharmaceutics Rexista Oxycodone XR Incorporating PODRAS Technology

Intellipharmaceutics International Inc. announced that the United States Food and Drug Administration ("FDA") has reviewed the Company's request for Fast Track designation for its abuse deterrent Rexista Oxycodone XR (Oxycodone HCl) extended-release tablets development program incorporating its Paradoxical OverDose Resistance Activating System (PODRAS ") and has concluded that it meets the criteria for Fast Track designation. Fast Track is a designation assigned by the FDA in response to an applicant's request which meets FDA criteria. The designation mandates the FDA to facilitate the development and expedite the review of drugs intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. This could potentially result in accelerated approval for Rexista Oxycodone XR thereby making it available to patients earlier than would be traditionally possible. Rexista Oxycodone XR is intended for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Such medications are considered important in the treatment of chronic pain, but have the potential for abuse. There can be no assurance that the Company will, as a result of the Fast Track designation for Rexista Oxycodone XR, experience a faster development process or review, compared to conventional FDA standards, or that the Company's Rexista Oxycodone XR product candidate will be approved at all, or that it will ever be successfully commercialized.

IntelliPharmaCeutics International Inc. Announces an Agreement to Acquire Real Property to House its Manufacturing, R&D and Office Facilities in Toronto, Ontario

Intellipharmaceutics International Inc. announced that it has agreed to purchase the land and building from which it conducts its operations at 30 Worcester Road, Toronto, Ontario as well as the land and building of the adjoining property at 22 Worcester Road for a combined purchase price of CAD 4,700,000. The operating property has been occupied by the Company since 2004 pursuant to a lease, and is approximately 25,000 sq. ft. The adjoining property includes a building of approximately 40,000 sq. ft. that is not currently occupied by the Company. The adjoining property is expected to provide the company with space that will permit expansion of the Company's operations. There can be no assurance that the purchase transaction will be completed. The Company's operating property has been its main site for over 10 years and comprises its management, R&D, manufacturing, quality control and analytical testing components. The United States Food and Drug Administration ("FDA") and Health Canada had previously granted "acceptable" classification to those aspects of the operating facility that permit the Company to be in a position to receive final approvals for certain drug applications and to permit manufacturing, testing, release and storage of drug products intended for commercial sales in the United States and Canada after any such approvals. No assurance can be given as to whether or when the FDA or Health Canada will approve any Intellipharmaceutics application for its product candidates, that its facility will continue to satisfy the requirements of the FDA or Health Canada, or that any of its product candidates will be successfully commercialized. The purchase transaction is subject to various closing conditions, including the company obtaining financing that is satisfactory to the company, and the property owner obtaining a municipal severance approval necessary for the transfer of the properties.


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