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USP Welcomes New Partners to “Fight the Fakes” Campaign

June 9, 2014 8:51 am | News | Comments

Established in 2013, the Fight the Fakes initiative now includes 25 healthcare groups, research institutes, foundations, non-profits and private sector organizations working together in the fight against fake medicines.     

USP Inaugurates Expanded Shanghai Facility

January 13, 2014 8:35 am | News | Comments

The U.S. Pharmacopeial Convention (USP), a nonprofit global health organization that creates and...

USP Announces Change in Labeling Requirement for Total Strength of Heparin to Help Minimize Medication Errors

November 5, 2012 5:24 am | News | Comments

To address safety concerns about the expression of drug strength on labels for heparin sodium...

USP Introduces Useful Guidelines on Sterilization and Contamination Control

May 15, 2012 6:32 am | by Radhakrishna Tirumalai, Ph.D., Principal Scientific Liaison, U.S. Pharmacopeial Convention | Articles | Comments

A product recall is problematic for any manufacturer. In the last year alone, recalls of...

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Standards Evolve to Meet Needs of Pharmaceutical Industry, Advance Public Health

October 20, 2010 10:16 am | by Desmond Hunt, Ph.D., U.S. Pharmacopeial Convention | Articles | Comments

The quality and safety of the U.S. (and international) drug supply has garnered much attention over the past year. Whether it is quality control problems in popular medications, heists resulting in stolen pharmaceuticals, substandard, adulterated, or counterfeit drugs being sold in developing countries (and even in developed nations), the industry has faced a barrage of negative headlines.

USP Advisory Panel Recommends Standardizing Prescription Container Labeling

May 11, 2010 5:17 am | News | Comments

To promote the establishment of universal standards for prescription medication labels -- and to address the widespread problem of patient misinterpretation of medication instructions -- an advisory panel formed by the U.S. Pharmacopeial Convention (USP) recently issued a set of recommendations to bring consistency to labeling on dispensed prescription packaging.

USP-WHO Study One-Third of Antimalarial Medicines Sampled in Three African Nations Found to be Substandard

February 8, 2010 9:15 am | News | Comments

The first results from a large-scale study of key antimalarial medicines in ten Sub-Saharan African countries reveal that a high percentage of medicines circulating on national markets are of substandard quality

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Teva Animal Health, Inc. Expands a Voluntary Nationwide Recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL Vials

December 22, 2009 3:45 am | News | Comments

Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level.

Lilly Announces the First 300-unit Vial of Insulin

December 8, 2009 3:29 am | News | Comments

Eli Lilly and Company today announced the availability of a smaller insulin vial, the first in the United States containing 3 mL (300 units) of insulin, for people with diabetes being treated in a hospital.

USP Clarifies Proposed Revised Standard for Labeling of Injectable Drug Vials

November 24, 2009 9:04 am | News | Comments

To help prevent medication errors that can occur in busy clinical settings, the U.S. Pharmacopeial Convention (USP) is posting a proposed revised standard for what should—and what should not—appear on the ferrules and cap overseals of medications vials.

FDA: New USP Standards for Heparin Products Will Result in Decreased Potency

October 1, 2009 9:18 am | News | Comments

The FDA has alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

Mylan Receives FDA Approval for Generic Version of Parkinson's TreatmentSinemet(R)

September 30, 2009 4:36 am | News | Comments

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has receivedapproval from the FDA for its AbbreviatedNew Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP,10mg/100mg, 25mg/100mg and 25mg/250 mg.

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FDA Approves APP Pharmaceutical's Deferoxamine Mesylate for Injection, USP

September 17, 2009 4:42 am | News | Comments

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., has received approval from the FDA to market Deferoxamine Mesylate for Injection, USP, in two dosage strengths.

Mylan Launches First Generic Version of Xopenex(R) Inhalation Solution (Concentrate), 0.25%

September 1, 2009 6:31 am | News | Comments

Mylan Inc.has announced that its subsidiary Mylan Pharmaceuticals Inc.has launched levalbuterol inhalation solution USP (Concentrate), 0.25%, (1.25 mg/0.5 mL). Mylan, which has already launched the product, will market this product with 180 days of exclusivity.

APP Pharmaceuticals Receives Approval for Penicillin G Potassium for Injection, USP

August 25, 2009 4:32 am | News | Comments

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the FDA to market penicillin G potassium for Injection, USP, in two dosage strengths.

He Who Hesitates Is Lost

July 8, 2009 6:22 am | Articles | Comments

Hesitation In The Drive To A Continuous Pharmaceutical Manufacturing Process: Real or Imaginary? By Girish Malhotra, PE President, EPCOT International Alphabets are the basic building blocks of any language. Our collective proficiency in them allows us to express ourselves to others.

Hesitation In The Drive To A Continuous Pharmaceutical Manufacturing Process: Real or Imaginary?

July 7, 2009 8:20 am | Articles | Comments

Alphabets are the basic building blocks of any language. Our collective proficiency in them allows us to express ourselves to others. Similarly, in the pharmaceutical manufacturing industry, we have to have complete command of its unique alphabet in order to successfully design and manufacture drugs.

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Mylan Receives FDA Approval for Additional Strength of Generic Restoril(R)

June 17, 2009 4:16 am | News | Comments

Mylan Inc.has announced that its subsidiary Mylan Pharmaceuticals Inc. has receivedapproval from the FDA for its supplementalAbbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg.This strength is in addition to Mylan's currently marketed 15 mg and 30 mgstrengths of the product.

Laboratory Compliance: Making The Grade

June 1, 2009 11:13 am | Articles | Comments

What is "laboratory compliance"? It is a general term used by many people, but which means different things to different people. There is no definitive answer or even one in Wikipedia the "on-line" encyclopedia!

Gasket Standardization: A New Tool for Cost Reduction in API Pharmaceutical Processes

June 1, 2009 11:12 am | Articles | Comments

The API pharmaceutical market has been increasingly buffeted by winds of global change. Even as new and innovative drugs have been developed and brought to market successfully, manufacturing operations have been increasingly challenged by the need to be more competitive and productive

Taro Receives FDA Approval for Sulfacetamide Sodium Topical Suspension ANDA

May 21, 2009 4:39 am | News | Comments

Taro Pharmaceutical Industries Ltd. reported today that its Canadian manufacturing site has received approval from the FDA for its Abbreviated New Drug Application for Sulfacetamide Sodium Topical Suspension USP, 10% (lotion) ("sulfacetamide sodium lotion").

Ranbaxy Voluntarily Recalls Nitrofurantoin Capsules in the U.S.

May 4, 2009 4:51 am | News | Comments

Ranbaxy Pharmaceuticals Inc. (RPI) is conducting a voluntary recall of all lots ofNitrofurantoin (Monohydrate/Macrocrystals) Capsules, USP 100 mg currently onthe market in the U.S.

12 Key Steps to Address USP Chapters and Changes

April 15, 2009 5:18 am | Articles | Comments

On May 1, 2009 the United States Pharmacopeia (USP) General Microbiology chapters will be harmonized with corresponding microbiology chapters in the European and Japanese Pharmacopeias (EP and JP).

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

March 11, 2009 12:32 pm | News | Comments

Schering-Plough Corporation has announced that the FDA has approved new labeling for PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy for treating chronic hepatitis C in patients 3 years of age and older with compensated liver disease.

Microbiology Innovation: The Evolution of Microbiological Methods Into The 21st Century at Ortho-Clinical Diagnostics (Rochester, NY)

March 6, 2009 7:00 am | Articles | Comments

Ortho-Clinical Diagnostics Microbiology Department in Rochester, NY, has demonstrated innovation by using the Process Excellence Define; Measure; Analyze; Innovative/Improvement; Control Road Map (DMAIIC) to improve the product release process. By selecting a rapid technology, testing cycle time was reduced as well as warehouse storage costs.

Alphabet Shuffle - Moving From QbA to QbD

February 23, 2009 10:41 am | by Girish Malhotra, PE EPCOT International, Pepper Pike, OH | Articles | Comments

Quality by Analysis (QBA) has been the MANTRA for manufacturing pharmaceuticals. This is due to the fact that, as we know, pharmaceuticals are manufactured using batch processes. Regulatory agencies would like the industry to move from QBA to QBD. QBD can result in a better batch process or a continuous process. Either of these process methodologies require a complete understanding of component chemistry and their mutual interaction.

One Hundred Pharmaceutical Water Systems Pitfalls Part V & #150; Microbial Control

February 18, 2009 6:38 am | Articles | Comments

A discussion of the pitfalls associated with microbial control in Pharmaceutical Water Applications

Objections Overruled!

February 9, 2009 9:08 am | Articles | Comments

Single-Use Components in Biopharmaceutical Manufacturing: Opportunities Outweigh Objections

USP Proposes Strengthened Partnership With HHS, FDA, To Help Protect Patients and Consumers

February 3, 2009 5:13 am | News | Comments

With the Obama administration’s renewed national focus on protecting public health, the U.S.

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