In recent weeks, the case of supplements containing an amphetamine-like substance called BMPEA has prompted FDA recalls; industry trade group condemnation; appeals from Congress for increased enforcement, consumer education campaigns and greater participation by ...
Established in 2013, the Fight the Fakes initiative now includes 25 healthcare groups, research...
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 ErrorsNovember 5, 2012 5:24 am | News | Comments
To address safety concerns about the expression of drug strength on labels for heparin sodium...
A product recall is problematic for any manufacturer. In the last year alone, recalls of pharmaceutical and health-related products have included baby lotions, parenteral nutrition products, nasal decongestant sprays and alcohol swabs used in preparation for patient injections—all resulting from microbial contamination.
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.
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 SubstandardFebruary 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
Teva Animal Health, Inc. Expands a Voluntary Nationwide Recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL VialsDecember 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.
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.
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.
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 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.
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 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, 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.
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.
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.
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.
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!
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 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 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.
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 CMarch 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.
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.
A discussion of the pitfalls associated with microbial control in Pharmaceutical Water Applications
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