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- November 28, 2012
Sagent Pharmaceuticals Announces Launch of Nafcillin for Injection, USP.
Sagent Pharmaceuticals, Inc. today announced the launch of Nafcillin for Injection, USP, in two vial presentations and one pharmacy bulk package bottle; all three are latex-free and preservative-free. According to IMS, for the 12 months ending September 2012, the US market for Nafcillin approximated $62 million. As with all products in Sagent's portfolio, Nafcillin features the Company's PreventIV MeasuresSM packaging and labeling, designed to help reduce medication errors.
Nafcillin for Injection, USP is a semisynthetic penicillin indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. It may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. It should not be used in infections caused by organisms susceptible to penicillin G.
- September 4, 2012
Astral Pharmaceutical Industries is now Astral SteriTech Private Limited.
We are pleased to announce that Astral Pharmaceutical Industries has been rechristened as ASTRAL STERITECH PRIVATE LIMITED and the Certificate of Incorporation from Registrar of Companies to this effect has been received.
The change in name is envisaged to emphasize on the core competence and niche activities of the firm i.e. sterile manufacturing with state of the art technology orientation.
We are now in the process of registering this change with various statutory bodies/authorities.
- August 24, 2012
Astral Pharmaceutical is granted approval for Nafcilin for injection by FDA.
Astral Pharmaceutical Industries has been granted approval for Naficilin for injection USP 1G, 2G and 10G.
- July 24, 2012
Launch of Oxcaillin for injection for the US market.
Sagent Pharmaceuticals, Inc. today announced the launch of Oxacillin for Injection, USP, in three latex-free, preservative-free vial presentations. According to IMS data for the twelve-months ended May 2012, the U.S. market for Oxacillin approximated $29 million. As with all products in Sagent's portfolio, Oxacillin features the company's PreventIV MeasuresSM packaging and labeling designed to aid in the reduction of medication errors.
Oxacillin for Injection, USP is a semisynthetic penicillin indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug.
- March 31, 2012
Sagent in collaboration with ASTRAL is granted approval for Oxacillin for Injection, USP 1g and 2g vials and Oxacillin for Injection, USP 10 g - Pharmacy Bulk products, by US FDA.
Sagent USA has filed several ANDA’s with ASTRAL. This is the first ANDA approval from our site and several more are expected in near future.
The latest US FDA inspection at ASTRAL was comprehensively successful. There were no audit observations i.e. without any 483's.
ASTRAL is expected to launch the Oxacillin range of products to US market during Q2 of 2012.
- April 20, 2010
Subsequent to the US FDA’s Pre Approval Inspection in January 2010, our both facilities – Semi Synthetic Penicillins (SSP) & Cephalosporins, are accepted by CDER, FDA to manufacture the products for US market.
- November 27, 2007
Sagent Pharmaceuticals Inc. and Astral Pharmaceutical Industries Announce Collaboration for Developing and Manufacturing Injectable Antibiotics. 27th November, 2007.
SCHAUMBURG, Ill., Nov. 27 /PRNewswire/ -- Sagent Pharmaceuticals, Inc.,
a privately-held specialty pharmaceutical company, and Astral Pharmaceutical Industries,
a global pharmaceutical manufacturing company
located in India, today announced an agreement in which Astral will
develop, manufacture and supply injectable products for which Sagent will
obtain U.S. regulatory approval and market in the United States.
"Sagent is committed to establishing strategic partnerships that
provide the most diverse and extensive pipeline for our hospital-focused
customers," said Jeffrey M. Yordon, CEO, founder and chairman of the board
of Sagent Pharmaceuticals, Inc. "We are thrilled to have the opportunity to
partner with Dr. Patel and Astral, a leading, worldwide manufacturer of
much needed antibiotic injectable products. This partnership in a key
therapeutic category strongly positions Sagent in our target markets."
"Astral is rapidly establishing a global footprint," said Dushyant R.
Patel, CEO, Astral Pharmaceutical Industries. "Collaborating with a partner
of Sagent's caliber in the United States is a fantastic opportunity for
Astral to quickly expand our science, quality and manufacturing expertise
in injectable anti-infectives to the U.S. market."
About Sagent Pharmaceuticals, Inc.
Sagent Pharmaceuticals, founded in 2006, is a privately held specialty
pharmaceutical company focused on developing, manufacturing, sourcing and
marketing pharmaceutical products, with a specific focus on injectable
products. Sagent has created a unique, global network of resources,
comprised of rapid development capabilities, sophisticated manufacturing
and innovative drug-delivery technologies, quickly yielding an extensive
portfolio of pharmaceutical products that fulfills the evolving needs of
patients. Sagent currently has more than 200 products in development.
For more information about Sagent, please visit
http://www.sagentpharma.com.
About Astral Pharmaceutical Industries
Astral Pharmaceutical Industries, located in Vadodara, India, is an
exclusive state-of-the-art manufacturing company specializing in sterile
antibiotic powder injectables. Founded in 1991, Astral was the first Indian
company to develop indigenous technology to manufacture sterile amoxicillin
sodium and has subsequently integrated into production of sterile
antibiotic powder formulations. Astral has independent and dedicated
facilities to manufacture injectable formulations for cephalosporin and
penicillin products.
For more information about Astral, please visit
http://www.astralpharma.com.
SOURCE Sagent Pharmaceuticals, Inc.
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