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Manufacturing

Sucampo signs exclusive global manufacturing and supply deal for lubiprostone By PBR Staff Writer
Sucampo Pharmaceuticals announced that its subsidiary, Sucampo, has signed an exclusive global manufacturing and supply agreement (EMSA) with its manufacturing and development partner, R-Tech Ueno (R-Tech), for clinical and commercial supplies of AMITIZA (lubiprostone) in most global markets.
Production & Manufacturing > Manufacturing > News
PSC Investments acquires sterile injectable facility from MIR By PBR Staff Writer
PSC Biotech’s subsidiary PSC Investments has acquired a high potency sterile injectable facility from the Morgridge Institute for Research (MIR).
Production & Manufacturing > Manufacturing > News GlaxoSmithKline plans to build new health drink units in Andhra Pradesh, India By CBR Staff Writer
GlaxoSmithKline Consumer Healthcare is planning to invest about $164m to set up a large health drink manufacturing facility near the east coast in southern Andhra Pradesh, India.
Production & Manufacturing > Manufacturing > News
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UK MHRA approves Cbris Lifesciences’ new facility
By PBR Staff Writer
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Claris Lifesciences’ newly commissioned facility (Plant 2).
Production & Manufacturing > Manufacturing > News
Regeneus, Cryosite to jointly manufacture human stem cell products
By PBR Staff Writer
Regeneus has signed an agreement with Cryosite to collaborate on the development and manufacture of new stem cell products for human applications.
Production & Manufacturing > Manufacturing > News
Apricus Biosciences announces launch of topical treatment for erectile dysfunction vitaros in Germany by Hexal
Apricus Biosciences (APRI), a biopharmaceutical company advancing innovative medicines to meet the needs of patients, has announced the launch in Germany of Vitaros, Apricus' novel topical on-demand treatment for erectile dysfunction (ED), by Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies (Sandoz).
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MediciNova releases positive interim results of Phase IIa MN-166 study in opioid dependence
By PBR Staff Writer
US-based biopharmaceutical firm MediciNova has released positive interim results from a Phase IIa clinical trial of MN-166 (ibudilast) in people with opioid dependence.
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Japan's Chugai Pharmaceutical denies Roche takeover reports
By PBR Staff Writer
Japan-based Chugai Pharmaceuticals has issued a statement denying Swiss drug giant Roche's takeover reports.
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Pragma Pharmaceuticals to re-launch once daily Moxatag
By PBR Staff Writer
Pragma Pharmaceuticals is planning to re-launch Moxatag 775mg (amoxicillin extended-release tablets), the first and only once daily amoxicillin.
Production & Manufacturing > Manufacturing > News
Acura provides update on FDA discussions on development of Aversion Hydrocodone with Acetaminophen tablet
Acura Pharmaceuticals has announced preliminary discussions from a meeting held with the U.S. Food and Drug Administration (FDA) regarding the development pathway for Acura's AVERSION hydrocodone with acetaminophen tablet development candidate, which is intended to provide abuse-deterrent features to address abuse by nasal snorting and injection.
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FDA accepts to review Pfizer's BLA for meningococcal B vaccine candidate
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review the Biologics License Application (BLA) Pfizer's vaccine candidate bivalent recombinant LP2086 (rLP2086) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in patients 10 to 25 years old.
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Global Services
Since its foundation in 1973, SOTAX has built an excellent reputation as a specialist in the manufacture of innovative, sophisticated and long-lasting instruments and systems for pharmaceutical testing, establishing the company as the leader in this technological field. To support this, SOTAX is certified for ISO 9001. For decades, customers have trusted our high-quality services and instrumentation.
Production & Manufacturing > Manufacturing > Products
Amgen issues voluntary recall of Aranesp (500 mcg) prefilled syringes outside US
Amgen has initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B, 1047394A, 1047622A, and 1047996A are being recalled as a precautionary measure.
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