Sagent Pharmaceuticals Announces Launch of First Two Oncolytic Products: Fludarabine Phosphate for Injection, USP and Epirubicin Hydrochloride Injection

SCHAUMBURG, Ill., Aug. 5 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched fludarabine phosphate for injection, USP and epirubicin hydrochloride injection. IMS data indicates the combined U.S. market...

Goal of good quality medicines advanced by new USP agreement with 9 ASEAN countries

Rockville, Md., June 24, 2009 Furthering its mission to improve the quality of medicines worldwide, the U.S. Pharmacopeial (USP) Convention has signed a cooperative agreement with nine countries belonging to the Association of Southeast Asian Nations (ASEAN). In a drive to strengthen capacities a...

Drive for good quality medicines, foods reinforced by USP agreements with Chinese drug authorities

Rockville, Md., June 19, 2009 As part of its efforts to improve the quality of medicines and food ingredients worldwide, the U.S. Pharmacopeial (USP) Convention this week reached three new cooperative agreements with Chinese drug control authorities. Because Chinese manufacturers supply so much o...

Microtest Offers New Services, Free Facility Audit, for Compounding Pharmacies Seeking USP 797 Compliance

AGAWAM, Mass., July 29 /PRNewswire/ -- Microtest Laboratories has launched a suite of services to assist the numerous compounding pharmacies in the U.S. that have yet failed to meet mandatory United States Pharmacopeia Chapter 797 (USP 797) regulations. Microtest also announced its offer of a ...

Amneal Receives FDA Approval for Bethanechol Chloride Tablets, USP Using New Expedited FDA Approval Process

PATERSON, N.J., Nov. 29 /PRNewswire/ -- Amneal Pharmaceuticals is pleased to announce that it received US FDA approval to manufacture Bethanechol Chloride Tablets, USP in strengths of 5mg, 10mg, 25mg and 50 mg, effective November 21, 2007. Bethanechol HCl is an AA-Rated, therapeutically equiva...

PharmaForce Inc. Receives FDA Approval for First Generic of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP

COLUMBUS, Ohio, July 31 /PRNewswire/ -- PharmaForce, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, a ...

Bedford Laboratories(TM) to Begin Shipping Ceftriaxone for Injection USP

BEDFORD, Ohio, July 16 /PRNewswire/ -- Bedford Laboratories(TM), a division of Ben Venue Laboratories, Inc., announced FDA approval to begin shipping Ceftriaxone for Injection USP. This product is AP rated and is equivalent to Rocephin(R) by Roche. Ceftriaxone is a semisynthetic, broad...

Sagent Pharmaceuticals Launches Amiodarone HCl Injection, USP

SCHAUMBURG, Ill., July 25 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched amiodarone HCl injection, USP, a class III antiarrhythmic indicated for the treatment and prophylaxis of frequently recurring ventricu...

Mylan Announces Final FDA Approval for Felodipine Extended-Release Tablets, USP

PITTSBURGH, April 21 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL ) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Felodipine Extended-release Tablets USP, 2.5 ...

Ranbaxy First to Gain Approval to Manufacture and Market Clarithromycin for Oral Suspension, USP

Ranbaxy One of Few Companies to Offer Both Suspension and Tablet Forms PRINCETON, N.J., Oct. 2 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug ...

Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL(R) 25 MG and 50 MG

...from the United States Food and Drug Administration on its Abbreviated New Drug Applications (ANDAs) for metoprolol succinate extended-release tablets usp in the 25 mg and 50 mg strengths. Metoprolol succinate extended-release tablets are the generic equivalent to AstraZeneca's Toprol XL(R) tablets. Me...

Patient safety advanced by revised heparin standards

...tten and physical standards for the widely used blood thinner. In February, usp released updated heparin standards at the request of the Food and Drug Admi...ientists and regulators at the third International Heparin Workshop held at usp headquarters in Rockville, Maryland, July 27󈞈. "While financia...

Counterfeit antimalarial drug discovered in Ghana

...mented by the U.S. Pharmacopeial (USP) Convention. usp is a nonprofit scientific organization that develo...the quality of medicines. Through the DQI Program, usp works in developing countries to help verify, assu...confirmed the medicine was indeed counterfeit. The usp DQI Program established the sentinel sites in coor...

Vietnamese drug authority teams with United States standards-setting organization

...MOU) with the U.S. Pharmacopeial (USP) Convention. usp is a scientific nonprofit organization that sets s...Food and Drug Administration in the United States. usp also sets standards for the identity and quality o...manufacturers look forward to working closely with usp to reach our shared goal of good quality medicatio...

New Compounding Pharmacy Videos Provide Product Information, Teach Safety

... for compounding of hazardous, sterile drug preparations in compliance with usp 797 criteria. Barrier isolation systems provide inherently superior sterili...   Introduction Risks Involving Cytotoxic Drug Preparation usp Guidelines & Requirements Types of isolators How Isolators Work S...

B. Braun Anticipates Becoming First to Deliver FDA Approved 2g Cefazolin

...on (FDA) approval for 2g Cefazolin for Injection usp and Dextrose Injection usp in B. Braun's DUPLEX(R) Drug Delivery System . ...de fast, safe, convenient and Joint Commission and usp Chapter < 797 > compliant products that impr...

Medication quality in Peru and region strengthened with official laboratory's accreditation

...nd how USP's quality management system complies with ISO standards. The usp DQI Program has supported quality assurance and quality control systems in ...ound the world in support of the foreign policy goals of the United States. usp DQI is a cooperative agreement with USAID that works to improve drug qualit...

Watson-Marlow Releases Informative Video Featuring Showcased High Purity Pumps, Tubing and Fillers at Interphex 2009

...utical grade tubing for peristaltic pumping and transfer use including platinum cured silicone, weldable Bioprene thermoplastic tubing, and additional usp Class VI materials. Manufactured in our own purpose built class ISO 14644-1/J/10,000 clean rooms, Pumpsil platinum cured silicone and Bioprene TPE ar...

CriticalPoint(TM) Training Rated 'Excellent' in Customer Satisfaction

...sfaction results. This system takes much of the administrative work out of usp < 797 > training compliance." Once a facility's training needs are e...raining, Academics and Resources (STAR) Center classroom-based training for usp < 797 > compliance and aseptic compounding. The CriticalPoint progra...

USP Applauds President's Budget Support for FDA

... toward increasing public confidence in FDA." usp is a scientific nonprofit organization that sets o... food ingredients and dietary supplements. FDA and usp have worked together for many years in a strong pu...zed and used worldwide. For more information about usp visit http://www.usp.org . FY0941 ...

Prematics Names S. Michael Ross Chief Medical Officer and Senior Vice President of Business Development

...e president of strategic business at the University of the Sciences in Philadelphia and as chief executive officer of Advanced Concepts Institute, a usp research group focused on the adoption of health information technology and its impact. Ross's other health care experience includes serving as...

US, Russian organizations team to improve the quality of medicines

...a's Ministry of Healthcare and Social Development. usp is an independent, non-profit organization that se...ies detailed in this agreement, Roszdravnadzor and usp will work to improve the quality of medicines that..."We look forward to a productive relationship with usp that ultimately results in a safer drug supply." ...

Astellas Launches Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia

...NTRAVIA (R) Container, a product of Baxter Healthcare Corporation, containing 20mg of conivaptan hydrochloride in 5% dextrose solution. Lactic acid, usp is added for pH adjustment to pH 3.4 to 3.8. The new formulation will make preparation easier for health care providers, as it requires no measuring o...

Oxford Performance Materials Introduces OXPEKK Colored Compounds

... properties and are available with ISO 10993 raw material certification and usp Class VI concentrate. "Of the commercially available polyketones O...KK-MG medical grade polymers which utilize an ISO 10993 tested material and usp Class VI tested concentrate. The products are produced in the firms ISO 134...

USP applauds nomination of Dr. Margaret Hamburg as FDA Commissioner

...environment." For more than a century, FDA and usp have worked closely in a unique partnership to ass...States Pharmacopeia. These standards, developed by usp with volunteers from the scientific community in an open public process, are enforced by FDA. usp also sets standards for food ingredients and dieta...

USP announces new standards to protect patients from counterfeit and adulterated medicines

...ay form a line of defense that helps to protect the public. " "These new usp quality standards provide better assurance of the quality of marketed produ... from reaching the marketplace. FDA is pleased to have worked together with usp on this effort." ...

New Standards Set for Heparin and Glycerin

...alled ethylene glycol and diethylene glycol," said usp Chief Science Officer Dr. Darrell R. Abernethy. "T...d-thinning properties, Abernethy explained. The usp had to fix the standard so that adulterated hepari...nited States, Abernethy said. In a first step, the usp did a "quick fix" last year, which dealt with the ...

APHA Lists Vitamin D Deficiency as Top Public Health Issue

...ing standards for the supplement industry. Additionally, Pharmavite also participates in the USP's Dietary Supplement Verification Program (DSVP). The usp (United States Pharmacopoeia) is a not-for-profit organization that has set pharmaceutical and dietary supplement quality standards since 1820. (...

Warner Chilcott and Watson Pharmaceuticals Announce Agreements on Loestrin(R) 24 and Femcon(R) Fe Patent Litigation

...ilcott has granted Watson a non-exclusive license to the U.S. patents covering Loestrin(R) 24 Fe (norethindrone acetate and ethinyl estradiol tablets, usp and ferrous fumarate tablets) and Femcon(R) Fe (norethindrone, ethinyl estradiol tablets, chewable, ferrous fumarate tablets). The agreement covering...

USP and NIBSC to collaborate on improved quality standards for biological medicines

...for traditional pharmaceuticals." Specifically, usp and NIBSC are considering the following collaborat... materials for biological products at NIBSC and in usp laboratories; Preparation of reference materials ... education or training programs and meetings. usp and NIBSC play key roles in the development, chara...

Baxa Announces 2009 Course Dates for Its STAR Center(R) Training Facility

...s focused on pharmacy best practice in relation to usp < 797 > regulatory compliance and hazardous ...ters south of Denver, Colorado. For 2009, Baxa and usp (United States Pharmacopeia) together bring you si...urse, Aseptic Processing and Compliance Tools for usp < 797 > . This two-and-one-half-day seminar ...

Alfacell Announces Management Update

...arketing and distribution agreements for ONCONASE have been secured with Megapharm Ltd. for Israel, BL&H Co. Ltd. for Korea, Taiwan and Hong Kong, usp Pharma Spolka Z.O.O., an affiliate of US Pharmacia, for Eastern Europe, and GENESIS Pharma, S.A. for Southeastern Europe. ONCONASE has been ...

Alfacell Reports Financial Results for First Quarter of Fiscal 2009

...arketing and distribution agreements for ONCONASE have been secured with Megapharm Ltd. for Israel, BL&H Co. Ltd. for Korea, Taiwan and Hong Kong, usp Pharma Spolka Z.O.O., an affiliate of US Pharmacia, for Eastern Europe, and GENESIS Pharma, S.A. for Southeastern Europe. ONCONASE has been ...

USP transitions medication error reporting programs

...esources on its core standards-setting activities, usp will transfer its reporting programs, MEDMARX and ...tively. This decision in no way signals a shift by usp away from its important patient safety efforts. Rather, usp will use data from these and other programs to enh...

USP wins CITAC award for paper on certified reference materials

...ation and value of USP's CRM program," said William Koch, Ph.D., USP's chief metrology officer. "This award is a reflection of the range of talents at usp that not only contributed to this article, but also made possible the CRM program at USP." ...

Baxa Corporation Announces Co-Marketing Agreement With Industry Leaders Pharmacy OneSource, Inc and ClinicalIQ LLC

...bring greater understanding of, and compliance to, usp < 797 > for the healthcare industry. ...ses on one of the three regulatory requirements of usp < 797 >: personnel training, facility design...uirements and helping users meet pharmacy-specific usp < 797 > compliance needs. The agree...

Frost & Sullivan Honours GELITA for Developing European Health Ingredient of the Year

...fied by the International Organisation for Standardisation (ISO) as well as by the Hazard Analysis and Critical Control Points (HACCP) process. "The usp of FORTIGEL(R) is the complete set of clinical data that provides testimony of its efficiency in the joint health segment," states Ghosh. "Meticulous ...

CutisPharma Announces Issuance of a Patent for Suppository Compounding

...ire kit aids the third party reimbursement process, reduces audit- related adjustments, and the use of these FIRST(R) kits facilitates compliance with usp Chapter . This patented container, kit, and the method will also be used for future suppository compounding kits such as Boric Acid, Morphine, and ot...

PharMEDium Agreement as Novation's Contractor for Outsourced Compounded Pharmacy Preparations

...olutions to more than 1,800 hospitals throughout the United States. The company complies with all applicable state laws and FDA regulations, including usp Chapter , and DEA requirements. ...

Baxa Corporation Launches The Virtual Compounder(TM)

...lPoint's training currently consists of 32 self-paced modules that meet the usp Chapter < 797 > competency assessment requirements. Through the Virtual C...raining, Academics and Resources (STAR) Center classroom-based training for usp compliance and aseptic compounding. Together, the programs represent a co...