Handa Pharmaceuticals News

Handa Pharmaceuticals Announces TruPharma’s U.S. Launch Of Its FDA-Approved ANDA for Lamotrigine Extended Release Tablets

Tainan City, Taiwan, June 6, 2017 — Handa Pharmaceuticals, Inc. (Taiwan Exchange: 6620) (together with its wholly owned U.S. subsidiary, Handa Pharmaceuticals, LLC, “Handa”), a specialty pharmaceutical company focusing on the research, development and commercialization of innovative prescription brand and high-barrier generic drug products, announced today that TruPharma, LLC (“TruPharma”) has started to market and [...]

June 6th, 2017|News|

Handa Pharmaceuticals, Inc. Announces FDA Approval for Generic Version of AstraZeneca’s SEROQUEL XR® Extended Release Tablets

Tainan City, Taiwan, May 10, 2017 — Handa Pharmaceuticals, Inc. (Taiwan Exchange: 6620) (“Handa”), a specialty pharmaceutical company focusing on the research, development and commercialization of innovative prescription brand and high-barrier generic drug products, announced that its partner, Par Pharmaceutical, Inc. an Endo International company (“Par”), received final approval from the U.S. Food and Drug [...]

May 10th, 2017|News|

Handa Pharmaceuticals Announces Endo Begins Shipping Generic Version of AstraZeneca’s SEROQUEL XR®

TAINAN TAIWAN, November 1, 2016 – Handa Pharmaceuticals, Inc. (“Handa”), a specialty pharmaceutical company based in Tainan, Taiwan, announced today that Par Pharmaceutical, Inc. (“Par”), an operating company of Endo International plc (NASDAQ: ENDP) (TSX: ENL) has begun shipping four dosage strengths (50 mg, 150 mg, 200 mg and 300 mg) of quetiapine fumarate extended [...]

November 1st, 2016|News|

Handa Pharmaceuticals Announces Tentative Approval of First-to-File ANDA for Takeda’s DEXILANT®

December 26, 2013 Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that the U.S. Food and Drug Administration ("FDA") has granted tentative approval of the Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, which Handa transferred to Par Pharmaceutical, [...]

December 26th, 2013|News|

Handa Pharmaceuticals Announces Acquisition and License Agreement with Par Pharmaceutical for Its First-to-File ANDA for AstraZeneca’s SEROQUEL XR®

October 29, 2012 Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that it has entered into an exclusive acquisition and license agreement with Par Pharmaceutical, Inc. for Handa's Abbreviated New Drug Application ("ANDA") for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca’s SEROQUEL XR®. Handa believes it is [...]

October 29th, 2012|News|

Handa Pharmaceuticals Announces Acquisition and License Agreement with Par Pharmaceutical for Its First-to-File ANDA for Takeda’s DEXILANT®

April 19, 2012 Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that it has entered into an exclusive acquisition and license agreement with Par Pharmaceutical, Inc. (NYSE: PRX) for Handa's Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, a generic version of Takeda's DEXILANT®. Handa believes that [...]

April 19th, 2012|News|

Handa Pharmaceuticals Announces Patent Litigation Settlement With AstraZeneca On its First-to-File ANDA for SEROQUEL XR®

October 3, 2011 Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that it has reached an agreement with AstraZeneca to settle its U.S. patent litigation regarding Handa's Abbreviated New Drug Application ("ANDA") for Quetiapine Fumarate Extended-Release Tablets 50 mg., 150 mg., 200 mg., 300 mg., and 400 mg., a [...]

October 3rd, 2011|News|

Handa Pharmaceuticals Announces Submission of Its First-to-File ANDA for Takeda’s DEXILANT®

March 2, 2011 Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, has been accepted for review by the U.S. Food and Drug Administration ("FDA"). Based upon available information, Handa [...]

March 2nd, 2011|News|