Drug Product

Type: Keyphrase
Name: Drug Product
First reported Sep 19 2014 - Updated 18 hours ago - 1 reports

United States : US FDA declares final permit to deal with Aurobindo's generic anti-infective drug in AMERICA [TendersInfo (India)]

The US Food & Drug Administration (USFDA) announced releasing final approval to yield as well as merchandise Aurobindo Pharma s generic version of Amoxicillin for oral suspension for dealing with infections in the American market.For oral suspension, ... [Published Pharmacy Choice - Sep 19 2014]
First reported Sep 18 2014 - Updated Sep 18 2014 - 1 reports

Morning Market Movers

EMCORE (NASDAQ: EMKR) shares jumped 34.50% to $5.77 after the company announced sale of Space PV to Veritas Capital for $150 million in cash.22nd Century Group (NYSE: XXII) shares gained 15.56% to $2.97 after the company reported that it has closed $10 ... [Published Benzinga.com - Sep 18 2014]
First reported Sep 18 2014 - Updated Sep 18 2014 - 1 reports

ICH elemental impurities guideline expected to be finalized at end of September

After much discussion and some confusion , the ICH’s (International Conference on Harmonization) Q3D guideline , which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.In the end, 24 elements ... [Published In-Pharmatechnologist - Sep 18 2014]
First reported Sep 17 2014 - Updated Sep 17 2014 - 1 reports

Industry groups take issue with FDA draft guidance on outsourcing facilities

body: The FDA's draft guidance, released in July, recognizes the differences between outsourcing facilities and commercial drug manufacturers and looks to tailor the cGMP requirements to the unique needs of the compounding industry. However, both BIO ... [Published AAPS Pharmceutica - Sep 17 2014]
First reported Sep 17 2014 - Updated Sep 17 2014 - 1 reports

Council set to vote on medical marijuana operation

The possibility of the city selling-off an eyesore might go up in smoke if council doesn't approve a zone change Thursday.The Woodstock company, Ontario Marijuana Growers (OMG), is asking council to consider changing the zoning on the former Thomas Built ... [Published Woodstock Sentinel-Review - Sep 17 2014]
First reported Sep 16 2014 - Updated Sep 17 2014 - 3 reports

Aurobindo Pharma receives USFDA approval for amoxicillin

The US Food and Drug Administration (USFDA) has granted final approval for the Hyderabad-based Aurobindo Pharma Limited to manufacture and market amoxicilin for oral suspension. This Abbreviated New Drug Application (ANDA) was approved out of unit 12, ... [Published Business Standard India - Sep 17 2014]
First reported Sep 16 2014 - Updated Sep 16 2014 - 1 reports

Designing and Sustaining Drug Stability Testing Programs: How to Extend Product Shelf Life

The pressure to develop compliant and cost-effective drug stability testing programs is enormous.In today’s hyper-competitive market, management wants products approved and on the market faster than ever.  And they want them to stay on shelves l ... [Published FDA News - Sep 16 2014]
First reported Sep 16 2014 - Updated Sep 16 2014 - 1 reports

Curtis & Coulter LLC Announce Upcoming Formulation Development & Bioequivalence Events

Image: http://www.accesswire.com/images/756/Curtis%20Coulter.jpgNew York / www.myprgenie.com / ACCESSWIRE / September 16, 2014 / Curtis & Coulter LLC, a new specialty life science events organizer is pleased to announce two new events specifically ... [Published 4 Traders - Sep 16 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 1 reports

Principal Scientist, Formulations, Early Biologics Development Job

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion ... [Published PharmaDiversity - Sep 15 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 1 reports

The Relevance of Industry Technical Associations

The objective of our industry is to manufacture and distribute high quality, healthcare products and therapies that benefit the public. One of the basic challenges to meeting this objective involves producing drug, biologic, and medical-device products ... [Published PharmTech.com - Sep 15 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 1 reports

Meeting the Challenges of Excipient Variability

Thomas Northcut/The physical and chemical properties of an excipient can have an impact on the manufacture and performance of the pharmaceutical products. With regulators placing increasing emphasis on quality by design (QbD) in product development, the ... [Published PharmTech.com - Sep 15 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 1 reports

QbD in API Manufacturing

Huchen Lu/With a quality-by-design approach, robust processes consistently deliver quality product.Small drug manufacturers looking to adopt a quality-by-design (QbD) approach aim to scientifically determine product and process characteristics that will ... [Published PharmTech.com - Sep 15 2014]

Quotes

Aurobindo said in a statement: "This Abbreviated New Drug Application (ANDA) has been approved out of Unit XII, Semi-Synthetic Penicillin (SSP) formulation facility in Hyderabad India."
...has been recognised internationally as a major clinical challenge," said Peter George, Group Chief Executive Officer at Clinigen Group plc. "We are therefore extremely proud to be making this potentially life-saving medicine available across Europe for people who may have no other suitable option to fight a life-threatening infection."
Burton-on-Trent, UK - 18 September 2014 - Clinigen Group plc ( "Clinigen' or the 'Group') (AIM: CLIN), the specialty global pharmaceutical company, today announced that the new first-in-class bactericidal, once-daily, injectable antibiotic VIBATIV® (telavancin), is now available to prescribe in Europe for the treatment of adults with nosocomial pneumonia (also known as hospital acquired pneumonia - HAP), including ventilator associated pneumonia (VAP), known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable."
Nigel Blackburn, Cancer Research UK's Director of Drug Development, said: "Recent advances in cancer immunotherapy have demonstrated the exciting potential of these treatments to improve outcomes in devastating diseases such as lung cancer. Better treatment options for lung cancer are badly needed and it is through collaborations such as this that we can save more lives sooner."

More Content

All (369) | News (266) | Reports (0) | Blogs (96) | Audio/Video (0) | Fact Sheets (0) | Press Releases (2)
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FDA: Don’t Use ‘Sterile’ Products From Downing ... [Published Pharmacy Practice News - 18 hours ago]
India,United States : FDA approves AUROBINDO PH... [Published Pharmacy Choice - 18 hours ago]
Sr. Technical Director [Published PharmaDiversity - 19 hours ago]
Specialist QA - Quality Risk Management [Published PharmaDiversity - 22 hours ago]
Reliability / Compliance Specialist [Published PharmaDiversity - Sep 19 2014]
Woodstock city council approves zoning for prop... [Published Woodstock Sentinel-Review - Sep 19 2014]
GUANGZHOU BAIYUNSHAN PHRMCL HLDGS : Baiyunshan ... [Published 4 Traders - Sep 19 2014]
United States : US FDA declares final permit to... [Published Pharmacy Choice - Sep 19 2014]
Baxter Recalls Potassium Chloride Injection: At... [Published PRWeb - Sep 19 2014]
FAST Generics Act Would Amend the FDC Act to Ad... [Published FDA Law Blog - Sep 19 2014]
Drug Information Update - FDA approves Trulicit... [Published Food Consumer - Sep 19 2014]
Who’s a “Foreign Official”? Supreme Court Could... [Published Main Justice - Sep 19 2014]
BioCryst Receives Additional NIAID Funding for ... [Published Virtual Strategy Magazine - Sep 18 2014]
BioCryst Receives Additional NIAID Funding For ... [Published Benzinga.com - Sep 18 2014]
BIOCRYST PHARMACEUTICALS : Receives Additional ... [Published 4 Traders - Sep 18 2014]
Clinigen Group plc : Clinigen Launch Antibiotic... [Published Investegate - Sep 18 2014]
Clinigen Launch Antibiotic, Vibativ in Europe [Published TrustNet - Sep 18 2014]
Cancer Research UK, Cancer Research Technology ... [Published FierceVaccines - Sep 18 2014]
Morning Market Movers [Published Benzinga.com - Sep 18 2014]
Biostar Pharmaceuticals, Inc. Files a PRC Paten... [Published Financial Services - Sep 18 2014]
ICH elemental impurities guideline expected to ... [Published In-Pharmatechnologist - Sep 18 2014]
"Abuse Resistant Forms of Extended Release Morp... [Published Pharmacy Choice - Sep 18 2014]
US FDA warns patients off all products from Tex... [Published In-Pharmatechnologist - Sep 18 2014]
PAUL ALLEN : Patent Issued for Crystalline Form... [Published 4 Traders - Sep 18 2014]
Industry groups take issue with FDA draft guida... [Published AAPS Pharmceutica - Sep 17 2014]
Potassium Chloride Injection (Baxter): Recall -... [Published U.S. Food and Drug Administration - Sep 17 2014]
QO Chemist – Specific Laboratory Location To Be... [Published PharmaDiversity - Sep 17 2014]
Council set to vote on medical marijuana operation [Published Woodstock Sentinel-Review - Sep 17 2014]
Jaguar Animal Health, Inc. Files Eighth Investi... [Published Enhanced Online News - Sep 17 2014]
Draft Guidance for Industry on Abbreviated New ... [Published Pharmacy Choice - Sep 17 2014]
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Blogs

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FAST Generics Act Would Amend the FDC Act to Ad... [Published FDA Law Blog - Sep 19 2014]
By Kurt R. Karst –There have been rumors floating around Washington, DC for a few months that efforts were afoot to introduce legislation to amend the FDC Act to address the availability of products subject to a restricted distribution program to generic ...
Springboarding Off of an HP&M Citizen Petition,... [Published FDA Law Blog - Sep 08 2014]
By Kurt R. Karst –  Last week, Connecticut Attorney General George Jepsen announced the submission of extensive comments to FDA that press the Agency to “exercise its discretion to immediately waive the 180-day waiting period and approve the sale” of ...
District Court Orders FDA to Recognize Orphan D... [Published FDA Law Blog - Sep 08 2014]
By Kurt R. Karst –Nearly two years after Depomed, Inc. (“Depomed”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s denial of orphan drug exclusivity for GRALISE (gabapentin) Tablets, the court (Judge Ketanji ...
Concert Pharma secures $2m payment for new drug... [Published PBR - News - Aug 27 2014]
Concert Pharmaceuticals has received a $2m milestone as part of a development and license agreement with Avanir Pharmaceuticals for the clinical progression of AVP-786 in patients with major depressive disorder (MDD). ...
FDA Puts Controls on Controlled Correspondence ... [Published FDA Law Blog - Aug 27 2014]
By Kurt R. Karst –This blogger’s oldest child started middle school this past week.  Naturally, I was excited to get his impressions of the first day of school.  “Good” was his initial comment – a now all to familiar one-word tween response.  So I pressed ...
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Press Releases

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Biostar Pharmaceuticals, Inc. Files a PRC Paten... [Published Financial Services - Sep 18 2014]
Ohr Pharmaceutical Announces Agreement to Acqui... [Published GlobeNewswire: Acquisitions News - May 15 2014]
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