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Sequella receives ARRA funds to manufacture SQ109 for treating tuberculosis

Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing novel antibiotics to treat life-threatening infectious diseases, today announced that it received a $694,000 grant supplement as part of the American Recovery and Reinvestment Act (ARRA) of 2009.

6 Oct 2009

Lupin grants Salix exclusive rights to its bioadhesive drug delivery technology for use with rifaximin

Salix Pharmaceuticals, Ltd. today announced that as of September 30, 2009 Lupin Ltd. granted Salix the exclusive right in the United States to its bioadhesive drug delivery technology for use with rifaximin. Salix and Lupin have entered into a development, commercialization and license agreement under which the two companies will collaborate in the development and commercialization of a product incorporating rifaximin and utilizing Lupin’s proprietary technology.

5 Oct 2009

$APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin$

APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ), and the leading supplier of heparin sodium to the U.S. market, announced today its continued support of the US Food & Drug Administration (FDA) and medical community for the October 1, 2009 implementation of the new United States Pharmacopeia (USP) monograph change for unfractionated heparin.

3 Oct 2009

Pharmatek to install the Xcelodose automated encapsulator system in San Diego

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it is the first CRO on the West Coast to acquire the Xcelodose system, enhancing the company's preclinical and early phase clinical GMP supply capabilities.

3 Oct 2009

Acuality Patient Classification System from API Healthcare

API Healthcare, the leading provider of human capital management solutions to the healthcare industry, today announced the general availability of the Acuality Patient Classification System, which allows hospitals to quickly assess patient care requirements and make appropriate future staffing assignments based on patient acuity levels.

3 Oct 2009

FDA completes inspection of Hovione's API plant in Loures, Portugal

Hovione's API plant in Loures, Portugal has just successfully passed a pre-approval inspection by FDA

1 Oct 2009

FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

30 Sep 2009

AFC announces the successful installation of three Hastelloy LLC in series

AMPAC Fine Chemicals (AFC), a subsidiary of American Pacific Corporation (Nasdaq: APFC), announced today the successful installation, qualification and validation in a cGMP manufacturing environment of a continuous extraction process consisting of three Hastelloy(TM) Liquid-Liquid Centrifuges (LLC) in series.

24 Sep 2009

Allocate Software and NHS Professionals renew contract for StaffBank application

Allocate Software plc, the leading provider of workforce optimisation solutions, and NHS Professionals, the largest provider of flexible staff managed services to the NHS, are pleased to announce the renewal of a contract for the provision of the StaffBank application.

24 Sep 2009

Biocryst signs agreement with three partners to represent its anti-viral peramivir outside U.S.

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has signed binding letters of intent with three partners who will exclusively represent BioCryst and its anti-viral peramivir for influenza stockpiling opportunities, as well as for marketing and distribution of peramivir for seasonal influenza upon local regulatory approval, within their territories outside the U.S.

15 Sep 2009

Mylan Pharmaceutical's ANDA for Teva's Copaxone accepted by FDA (Correction)

Mylan Inc. (Nasdaq: MYL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Mylan Pharmaceutical Inc.'s abbreviated new drug application (ANDA) for Glatiramer Acetate Injection (20 mg/mL), a generic version of Teva's Copaxone(R), a product indicated for the treatment of multiple sclerosis.

14 Sep 2009

JDA Software helps pharmaceutical companies enhance supply-chain management

Successful supply chain management, including managing demand, planning API and formulation production, packaging and distributing, is a goal shared by all pharmaceutical manufacturers. According to PharmaTech.com, effective supply-chain management is particularly important as the pharmaceutical industry seeks ways to reduce costs, maintain regulatory compliance, and adhere to quality and safety standards.

3 Sep 2009

Ariba podcast to help pharmaceutical companies conduct cost-effective sourcing

With expiring patents and growing gaps in revenue a reality in today’s global pharmaceutical industry, an increasing number of drug manufacturers are beginning to evaluate their supply chains to identify any and all opportunities for savings so that they can continue to bring innovative products to market and remain competitive.

1 Sep 2009

Mylan's subsidiary notified by the WHO Prequalification of Medicines Programme

Mylan Inc. today is pleased to announce that its subsidiary Matrix Laboratories Ltd. has been notified by the World Health Organization (WHO) Prequalification of Medicines Programme that the WHO has withdrawn its notice of concern for Matrix Unit 8, which is located in the Vizianagaram District of India, with no remaining concerns outstanding.

29 Aug 2009

Mylan Pharmaceuticals markets FDA approved first generic version of Sanofi Aventis' BenzaClin

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market 1% Clindamycin and 5% Benzoyl Peroxide Gel based on an agreement with licensing partner Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International. The preparation is the first generic version of Sanofi Aventis' BenzaClin(R) to be approved by the U.S. Food and Drug Administration (FDA).

27 Aug 2009

FDA accepts Labopharm's response for its novel trazodone formulation

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug Administration (FDA) has accepted Labopharm's response regarding its novel formulation of the antidepressant trazodone as complete and designated it as a Class 2 resubmission. The FDA has assigned Labopharm a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010.

26 Aug 2009

FDA issues warning letter to Cambrex concerning its Italian API manufacturing facility

Cambrex Corporation (the "Company") announced that it has received a warning letter from the U.S. Food and Drug Administration ("FDA") relating to an inspection of the Company's generic active pharmaceutical ingredient ("API") manufacturing facility located in Milan, Italy in March 2009. The observations noted in the warning letter are primarily related to the collection and maintenance of certain laboratory data.

25 Aug 2009

Orient Pharma granted commercialization rights for a drug candidate by DURECT

DURECT Corporation today announced that it has signed a development and license agreement with Orient Pharma Co., Ltd., a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan, under which DURECT has granted to Orient Pharma development and commercialization rights in selected Asian and South Pacific countries to a drug candidate based on DURECT's ORADUR(R) Technology and one specified active pharmaceutical ingredient for the treatment of attention deficit hyperactivity disorder (ADHD).

19 Aug 2009

API Healthcare offers new business analytics solution for enterprise workforce information analysis

API Healthcare, the leading provider of human capital management solutions to the healthcare industry, today announced the availability of its new Business Analytics solution, a software application that provides hospitals and health systems with a centralized source for analyzing workforce information across the enterprise.

19 Aug 2009

Labopharm submits response to FDA for formulation of the antidepressant trazodone

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has submitted its response to the U.S. Food and Drug Administration's (FDA) complete response letter regarding the Company's novel formulation of the antidepressant trazodone.

11 Aug 2009

Active Pharmaceutical Ingredient API News and Research

Sequella receives ARRA funds to manufacture SQ109 for treating tuberculosis

Lupin grants Salix exclusive rights to its bioadhesive drug delivery technology for use with rifaximin

APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin

Pharmatek to install the Xcelodose automated encapsulator system in San Diego

Acuality Patient Classification System from API Healthcare

FDA completes inspection of Hovione's API plant in Loures, Portugal

FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

AFC announces the successful installation of three Hastelloy LLC in series

Allocate Software and NHS Professionals renew contract for StaffBank application

Biocryst signs agreement with three partners to represent its anti-viral peramivir outside U.S.

Mylan Pharmaceutical's ANDA for Teva's Copaxone accepted by FDA (Correction)

JDA Software helps pharmaceutical companies enhance supply-chain management

Ariba podcast to help pharmaceutical companies conduct cost-effective sourcing

Mylan's subsidiary notified by the WHO Prequalification of Medicines Programme

Mylan Pharmaceuticals markets FDA approved first generic version of Sanofi Aventis' BenzaClin

FDA accepts Labopharm's response for its novel trazodone formulation

FDA issues warning letter to Cambrex concerning its Italian API manufacturing facility

Orient Pharma granted commercialization rights for a drug candidate by DURECT

API Healthcare offers new business analytics solution for enterprise workforce information analysis

Labopharm submits response to FDA for formulation of the antidepressant trazodone

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