Sigma-Aldrich receives ISO 13485 certification

Sigma-Aldrich Corporation, a leading life science and high technology company, has received ISO 13485 certification for expanded quality assurance capabilities at its Dekalb and Barton facilities located in St. Louis.

The certification extends Sigma-Aldrich's ability to manufacture and offer critical raw materials, such as enzymes, proteins and antibodies used in diagnostic assays, and provides in vitro diagnostic (IVD) customers with industry-leading assurance of consistent quality to meet and exceed their supply chain needs at a time of increased regulatory requirements.

The Dekalb site, which manufactures enzymes and proteins, achieved the ISO 13485 certification following significant investments in production and packaging facilities as well as personnel training. A similar commitment to invest in capabilities for the diagnostics customer segment enabled ISO 13485 certification of quality management systems at the state-of-the-art Barton distribution warehouse, that can now serve as a central North American distribution center for Sigma-Aldrich raw materials designed for use in IVD manufacturing applications. These two St. Louis-based sites join the growing roster of ISO 13485 certified facilities located in Jerusalem and Rehovot (Israel, obtained in Q4 of 2014), which manufacture antibodies and enzymes, as well as the St. Louis Ewing site, which provides OEM assay manufacturing services to diagnostic customers.

As one of the leading suppliers of raw materials to the diagnostic market, Sigma-Aldrich made an investment to extend its ISO 13485 certification based on the company's assessment of clients' current and future needs. Sigma-Aldrich continually invests in quality assurance initiatives and has 44 Quality Control laboratories worldwide, as well as approximately 800 employees within the Sigma-Aldrich Quality organisation.

Pfizer plans to close its 50-year old Thane facility in September

Pfizer, a Rs. 1,800 crore plus pharma MNC after merging Wyeth, has decided to shut down its over 50 years Thane facility from September 16, 2015. The decision to close the site is based on an assessment its long term viability and its ability to achieve the needed production. There has practically been no production activity at this plant since 2013, and the closure will not impact the supply of any of our medicines to patients.

The company had offered a generous voluntary retirement scheme (VRS) to the workmen at this site last year, upon their request. This was taken up by as many as 132 of the 212 workmen. The remaining 80 workmen have continued to receive full wages, despite plant inactivity. As a part of the closure process, the company will honour its obligations towards requisite compensation, as mandated by law, for the remaining workmen. We are grateful for the contribution of the workmen and colleagues and will ensure that they are treated with fairness and respect.

Pfizer remains committed to providing high quality medicines to our patients and customers in India.

Dr Reddy's launches OTC hair care drug Hairootz

Hairootz comes from the same branch of business that markets Mintop, a solution used for prevention of hair loss.
 
Studies reveal that more than 58 percent of men aged 30-50 years suffer from a common type of hair loss, due to modern lifestyles which has brought about various nutrition related deficiencies and diseases, hair loss being one of them. Hairootz provides key nutrients needed for maintaining healthy hair. Stressful lifestyles often lead to hair greying and hair loss.
 
“Hairootz’s unique formula has grape seed extract containing potent antioxidants, which are 20 times greater than vitamins E & C 2. Other key ingredients include Biotin which helps prevent excessive hair loss, minerals which have shown to reduce hair thinning, breakage and prevent dandruff and greying. It also includes key amino acids which would promote hair growth by improved blood circulation to hair roots,” said Dr Reddy’s in a press release.

Syngene gets FIPB approval with foreign investment limit to 44%

Syngene International, one of the leading India-based Contract Research Organisation (CRO) and a subsidiary of Biocon Ltd, has received the Foreign Investment Promotion Board (FIPB) approval for raising the foreign investment to 44 per cent from the earlier approved 10 per cent by way of its Initial Public Offering (IPO).

Commenting on the development, Peter Bains, chief executive officer, Syngene International, said, “We are happy to receive the FIPB approval to increase the foreign investment limit in our company. Syngene supports the global pharmaceutical, biotech and life science industries; this approval will enable us to look to broaden our global investor base.”

The IPO is an offer for sale (OFS) by Biocon of a part of its shareholding in Syngene. The Biocon Group presently holds 83.6 per cent equity stake in Syngene.

Syngene reported revenues of Rs. 7,077 million for FY 2013-14 and Rs. 6,175 million for 9 month ended December 31, 2014. For the three fiscal years ended March 31, 2014, its total revenue, restated profit and EBITDA grew at compounded annual growth rates (CAGR) of 29.9 per cent, 70.5 per cent and 30.6 per cent, respectively. Its flexible business models, expertise in managing large integrated collaborations and world-class infrastructure has not only helped it renew and expand its existing client collaborations but also in attracting new clients. Syngene’s client base increased 90 per cent from 103 in FY 2012 to 195 as on December 31, 2014.

Jubilant Life Sciences' levofloxacin tablets receives ANDA approval

Jubilant Life Sciences Ltd, an integrated global pharmaceuticals and life sciences company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for levofloxacin tablets, 250mg and 500mg.

Levofloxacin tablets, the generic version of Levaquin tablets of Ortho-McNeil, is used for the treatment of adults with infections such as pneumonia, bacterial sinusitis, chronic bronchitis, skin and skin structure infections, chronic bacterial prostatitis, urinary tract infections and inhalational anthrax. The total market size for Levofloxacin tablets as per IMS is $28 million per annum.

As on March 31, 2015, Jubilant Life Sciences had a total of 806 filings for formulations of which 368 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 Dossier filings in Europe.

The company is engaged in manufacture and supply of APIs, solid dosage formulations, specialty pharmaceuticals and life science ingredients. It also provides services in contract manufacturing and drug discovery solutions.

D-Pharm announces positive phase 2 study results of THR-18 in acute stroke patients

D-Pharm Ltd., a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders, has received the final report for its phase 2 clinical study of THR-18. THR-18 demonstrated statistically significant reductions in the incidence of intracranial hemorrhage (ICH), brain swelling (edema) and a satisfactory safety profile in stroke patients treated with tPA. Moreover, stroke recovery was improved 2-fold in patients receiving THR-18, as judged by clinical outcome measures, 30 days following stroke.

THR-18 is a novel drug-candidate designed to neutralize or reduce the life-threatening adverse effects of thrombolytic therapy with tPA. This double-blind, placebo-controlled, escalating single-dose, Phase 2 study was the first to assess the safety, pharmacodynamics and pharmacokinetics of THR-18 and tPA in AIS patients. The study results were presented last month at the European Stroke Organization conference in Glasgow.

The study successfully defined the maximal tolerated and safe dose of THR-18 in AIS patients. The imaging data as assessed by CT (computed tomography) on day 2 following stroke and tPA treatment indicate that, in contrast to the placebo group, no patients treated with THR-18 had an intracranial hemorrhage, (p=0.02). Similarly, 0.54 mg/kg of THR-18 reduced by more than twice the occurrence of brain edema (p<0.05). 

Iroko Pharma receives US patent for Zorvolex

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has received patent from the United States Patent and Trademark Office (USPTO) for the composition of matter covering Zorvolex (diclofenac) capsules 18 mg or 35 mg to treat mild to moderate acute pain and osteoarthritis pain.

The patent will be listed in the US Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, or Orange Book. Zorvolex which is approved by the US Food and Drug Administration (FDA) is available at pharmacies across the United States.

“We are excited to receive yet another patent on our flagship product, Zorvolex, which is another testament to our ongoing, successful collaboration with iCeutica,” said Osagie Imasogie, executive chairman of the Board and chief executive officer of Iroko Pharmaceuticals.

The term of the issued patent expires no earlier than 2030. In addition, Zorvolex has three years of regulatory exclusivity from date of product approval through FDA’s regulatory pathway. Iroko and iCeutica continue to prosecute additional patent applications for these and other products in the Iroko portfolio.