Sentences with phrase «manufacture of generic drugs»

Created in 1993, the act concerns the manufacture of generic drugs.

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

After graduating from the University of Calcutta in 1982, Dilip Shanghvi started working at his father's wholesale generic - drugs business, where he saw an opportunity to manufacture Lithosun, a drug that treated manic - depressive disorders and was unavailable in much of eastern India.

The research behind a new drug is protected for a fixed number of years, after which competing firms can begin manufacturing generic forms.

«We are calling for the generic manufacture and widespread availability of the drug flucytosine, and plan large - scale programmes of implementation with partner countries and international agencies that could result in the mortality from this dreaded infection being halved.

Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved, although the labeling of the generic risperidone might differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity, the agency said.

(That's different from manufacturing a small - molecule generic, which will have the exact chemical structure of the brand - name drug.)

This could be great too as Jean - Coutu owns a generic drug brand and manufacture but... I think that in Ontario or another province, they recently forbid pharmacists to also be owners of drug manufactures... So time will tell but I expect a lot of volatility with that title for a while.

Like many drugs, there are a number of names by which Clomipramine can go by, including Anafanil (made by Novartis,) Clomicalm (manufactured by Novartis) or the generic Clomipramine Hydrochloride.

Ratiopharm Inc. v. Canada (Attorney General) 2014 FC 502 Constitutional Law — Statutes — Trade Regulation Summary: Ratiopharm Inc. sold generic drugs in Canada, including ratio - salbutamol HFA («ratio HFA»), the generic equivalent of Ventolin HFA, a product manufactured by GlaxoSmithKline Inc. (GSK).