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USP in Medical News

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 ...

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USP in Medical Technology

Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP

PRINCETON, N.J., Aug. 20 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Hydrocodone Bitartrate and Acetamino...

Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)

... the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HC1, usp and niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain. (Logo: http://www.newscom.com...

Alfacell Provides ONCONASE(R) NDA Submission 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 ...

Paper in Molecular Cancer Therapeutics Reports that a Novel Combination of Alfacell's ONCONASE(R) and Rosiglitazone Induces a Synergistic Apoptotic Effect in Several Cancer Cell Lines

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

Alfacell Announces ONCONASE(R) Distribution and Marketing Agreement with Megapharm for Israel

...harmaceutical, Inc. Strategic marketing and distribution agreements for ONCONASE have been secured with 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 granted ...

AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication

...venous site and or tubing. The intravenous line should always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer's Injection, usp or 5% Dextrose Injection, USP both prior to and after administration of NEXIUM I.V. for Injection. Treatment with NEXIUM I.V. for Injection should b...

Alfacell Corporation Announces Preliminary Results From ONCONASE(R) Phase IIIb Clinical Trial

...harmaceutical, Inc. Strategic marketing and distribution agreements for ONCONASE have been secured with 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 granted ...

Watson Launches Generic Biaxin(R) XL

...rmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical company, announced today it has launched Clarithromycin Extended-Release Tablets, usp in the 500 mg strength. Watson's Clarithromycin Extended-Release product is the generic equivalent to Abbott's Biaxin(R) XL, which is indicated to tre...

Raydiance Collaborates With Rutgers University and Nation's Largest Tissue Bank to Develop Innovative Tissue Processing Approaches

...ntists Leveraging Precision and Power of Raydiance usp Laser Platform to Separate Skin Layers Without C...s and MTF on this important project. The Raydiance usp laser platform is unlocking disruptive innovation ...ect will focus on demonstrating the feasibility of usp laser processing of donor skin in the following ar...

European Experts Recommend Pregnant and Nursing Women Take More DHA - Every Day

.... The omega-3 in Animi-3 is all natural, purified to eliminate any contaminants such as heavy metals or PCBs, and comes from a source that has earned usp verification. For more information on Animi-3, visit http://www.animi-3.com . Source: http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=26...
USP in Medical Products

Triad Plus Sterile Isopropyl Alcohol 70% USP and 10% Acetone Alcohol Prep Pads

Description: Triad Plus Sterile Isopropyl Alcohol 70% USP and 10% Acetone Alcohol Prep Pads are primarily used as a topical antiseptic, anti-infective prior to administering injections. Acetone Alcohol provides an effective removal of oils and fats from the skin. They are gamma sterilized to meet AAMI/A...
Company:Triad Group, Inc.

Triad Plus Sterile Isopropyl Alcohol 70% USP Prep Pads

Description: Triad Plus Sterile Isopropyl Alcohol 70% USP Prep Pads are medium size. Each package is terminally sterilized, ensuring the safest possible product....
Company:Triad Group, Inc.

Triad Plus Sterile Isopropyl Alcohol 70% USP Swabsticks

Description: Triad Plus Sterile Isopropyl Alcohol 70% USP Swabsticks are primarily used as a topical antiseptic prior to administering injections. They are gamma sterilized to meet AAMI/ANSI/ISO 11137 standards to contain a consistent amount of alcohol ensuring a complete procedure....
Company:Triad Group, Inc.

Triad Plus Sterile Isopropyl Alcohol 70% USP and 10% Acetone Swabsticks

Description: Triad Plus Sterile Isopropyl Alcohol 70% USP and 10% Acetone Swabsticks are primarily used as a topical antiseptic, anti-infective prior to administering injections. Acetone Alcohol provides an effective removal of oils and fats from the skin....
Company:Triad Group, Inc.

Biotrace Sterile Barium Sulfate USP

Description: Biotrace Sterile Barium Sulfate USP is specifically designed to provide superior guidance and consistent imaging capabilities for todays medical professionals who administer bone cement via minimally invasive surgery. Comprised of a uniform particle size, Biotrace provides an even diffusion of ster...
Company:Bryan Corporation

Sculptra® Injectable Poly-L-Lactic Acid

Description:...gradable, synthetic polymer from the alpha-hydroxy-acid family. SCULPTRA is reconstituted prior to use by the addition of Sterile Water for Injection, usp (SWFI) to form a sterile non-pyrogenic suspension....
Company:Dermik Laboratories

Triad Plus PVP-I Scrub swabsticks

Description:... Triad Plus PVP-I Scrub swabsticks is formulated with an antimicrobial surgical cleanser containing to prevent dryness. It contains 7.5% PVP-I, usp solution equivalent to 0.75% available iodine. Povidone-Iodine is known to kill skin surface pathogens, including gram-negative and gram-positive ...
Company:Triad Group, Inc.

Triad Plus PVP-I Prep Swabsticks

Description:... Triad Plus PVP-I Prep Swabsticks are saturated with a 10% Povidone Iodine, usp solution equivalent to 1% available iodine. Povidone Iodine is virtually non-irritating to skin, wounds or mucus membranes. It is also non-stainin...
Company:Triad Group, Inc.

Tincture of Iodine Saturated Swabsticks

Description:...isely the correct amount of solution. Each package is terminally sterilized, ensuring the safest possible product for the patient. Iodine Tincture, 2% usp Saturated Swabsticks are an excellent combination of ethyl alcohol and iodine creating a potent disinfectant. It is recommended by the CDC as a highly...
Company:APLICARE Inc.

Triad Plus Povidone Iodine (PVP-I) Sponge Sticks

Description:...ne (PVP-I) Prep Sponge Sticks are saturated with a 10% Povidone Iodine, usp solution equivalent to 1% available Iodine. Triad Plus Povidone Iodine (PVP-I) Scrub Sponge Sticks are saturated with a 7.5% Povidone Iodine, usp solution equivalent to 0.75% available Iodine....
Company:Triad Group, Inc.

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USP in Biological News

Dietary supplements manufacturers gain new tool to help ensure quality products

...ay by the U.S. Pharmacopeial (USP) Convention. The usp Dietary Supplements Compendium (DSC) will also hel...elease of this new Dietary Supplements Compendium, usp is seeking to partner with ingredient suppliers, d...med misbranded by FDA if they fail to so conform). usp has been setting quality standards for medicines f...

Infant formula adulteration with melamine underscores need for better detection methods

... sweetener glycerin in toothpaste and cough syrup. usp is a scientific nonprofit organization that sets o...rength of prescription and over-the-counter drugs. usp also sets widely recognized standards for the qual...rtify foods for human and animal consumption. usp publishes the Food Chemicals Codex (FCC), a collec...

Quality and purity of popular stevia sweetener strengthened by new reference standards

...hroughout the world. The new stevia standards demonstrate the commitment of usp to continue to support the food industry with quality monographs and refere...roducts to demonstrate the quality of their ingredients to their customers. usp is well poised and committed to providing useful tools for enabling interes...

New standard for popular stevia-based sweetener to assure product's quality

...turers assure the product's quality for consumers. usp is seeking comments from the food and beverage ind...rties via the FCC Forumthe mechanism through which usp accepts public comment on standards to be included...velopment of and subsequently choose to adhere to, usp and food and beverage manufacturers can partner to...

American Chemical Society's Weekly PressPac -- Dec. 3, 2008

...to interpret, and generally not quantitative, according to the article. usp now is developing new standards and testing methods that will be finished in 2010 and implemented over a span of years. usp will require drug makers to use improved methods and instruments to detect ...

PharMEDium Announces National Rollout of Electronic 222 Ordering Initiative

...naged by licensed pharmacists and staffed by certified technicians, the company complies with all applicable state laws and FDA regulations, including usp Chapter and DEA requirements. Contact: Amy Langan, MEDIA INQUIRIES: Jon Ross, PharMEDium Director of Market...

Prednisone tablets less variable than marketed drugs

...f a study comparing the dissolution variability of usp Prednisone Lot P Reference Standard tablets to two...gs. Study results clearly show less variability in usp Prednisone Lot P tablets than in the marketed tabl... results. These activities are detailed in various usp General Chapters, particularly Dissolution . For ...

USP Convention and Chinese Pharmacopoeia Commission sign Memorandum of Understanding

...ted States and China. Roger L. Williams, M.D., usp executive vice president and CEO, and Wu Zhen, sec...ChP and the SFDA joined Mr. Wu in visiting USP. usp is pleased to partner with the Chinese Pharmacopoe...ion looks forward to a long-term relationship with usp in which we exchange our scientific expertise and ...

Raydiance collaborates with Rutgers, MTF to develop innovative tissue processing approaches

...hted to work with Rutgers and MTF on this important project. The Raydiance usp laser platform is unlocking disruptive innovation across a range of industr...initial phase of the project will focus on demonstrating the feasibility of usp laser processing of donor skin in the following areas: Separation of ...

Market testing of dietary supplements and drugs underscores value of USP's public health programs

...ry Supplement Verification Program and carries the usp Verified mark. In response to the report, usp studied the verified product to confirm the announ...lso demonstrated that the tablet in question meets usp dissolution requirements. USPs analysis showed tha...
USP in Biological Technology

Sagent Pharmaceuticals Announces Expansion of Cefazolin Product Line to Include Cefazolin for Injection, USP in 500mg Single-Dose Vial

SCHAUMBURG, Ill., Feb. 9 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched Cefazolin for injection, USP, an essential antibiotic used to treat serious infections, in a 500mg single-dose vial. The 500mg s...

New USP 797 Regulations May Create New Hazards for Compounding Pharmacy Directors

AGAWAM, Mass., Sept. 23 /PRNewswire/ -- Though the new USP 797 regulations, which become effective June 1st, ease testing requirements, the impact of following the new minimums has the potential of creating new hazards for compounding pharmacy directors, warns Steven Wieczorek, Supervisor, Env...

FDA Approves Fougera's Clotrimazole Cream USP 1%

MELVILLE, N.Y., Sept. 12 /PRNewswire/ -- Fougera, a division of Nycomed US Inc., today announced the FDA has approved its Clotrimazole Cream USP 1%. The generic formulation compares to Taro's Referenced Listed Drug (RLD) and is available in three sizes: 15g tubes (NDC # 0168-0133-15), 30g tube...

Sagent Pharmaceuticals Launches Ceftazidime for Injection, USP

SCHAUMBURG, Ill., July 24 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched ceftazidime for injection, USP, a semisynthetic broad-spectrum, beta-lactam antibiotic. Sagent will offer ceftazidime in 1 and 2g sing...

Sagent Pharmaceuticals Launches Ceftriaxone, USP, and Cefuroxime for Injection, USP

SCHAUMBURG, Ill., July 16 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched both ceftriaxone for injection, USP, and cefuroxime for injection, USP, two broad spectrum antibiotics for parenteral administration u...

Sagent Pharmaceuticals Launches Cefazolin for Injection, USP

SCHAUMBURG, Ill., March 13 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company today announced that it has launched Cefazolin for injection, USP, an essential antibiotic used to treat serious infections. Sagent's Cefazolin for injection will be avail...

Using the SpectraMax Plus for USP Dissolution Calibration (MaxLine Application Note #27)

INTRODUCTION Calibration of a dissolution apparatus is necessary to produce accurate results for dissolution testing of pharmaceutical dosage forms and to allow comparison between batches and between laboratories. USP requirements for calibration are given in the Appa...

Saint-Gobain Introduces Next Generation Silicone Tubing

...at pass through the tubing. Sani-Tech(R) Ultra products are fully characterized, validated and tested to a variety of specifications, including usp Class VI, ISO 10993 and EP 3.1.9. Detailed testing protocols are available upon request. Saint-Gobain Performance Plastics' silicone tubing is ...

Spherix Announces Full-Scale Production of Pharmaceutical Tagatose

...al companies, today announced that it has received its first full-scale production batch of cGMP (FDA Current Good Manufacturing Practice) D-tagatose, usp (U.S. Pharmacopeia) grade. One metric ton of drug was received from the manufacturer, Inalco S.p.A., of Italy. Spherix will use the tagatose in the ...

Bioniche Pharma Launches Enlon(R) and Enlon-Plus(R) Injection

...turer of injectable pharmaceuticals, announced the launch of Enlon (R) (edrophonium chloride injection, USP) and Enlon-Plus(R) (edrophonium chloride, usp and atropine sulfate, USP) Injection. (Logo: http://www.newscom.com/cgi-bin/prnh/20080702/AQW070LOGO ) "The acquisition and launch of Enl...

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