Company Milestones
Zydus Pharmaceuticals (USA) Inc. currently offers over 170 FDA-approved generic products across a wide variety of therapeutic categories in the US, as well as several branded FDA-approved products, which you can learn more about here. Our company’s history is outlined below – select one of the time frames to explore further.
Zydus Pharmaceuticals (USA) Inc. incorporates in New Jersey on November 18, 2003.
Zydus (USA) files its first Abbreviated New Drug Application (ANDA).
First product, atenolol tablets, is launched.
Acquisition of the assets of Nesher Pharmaceuticals, Inc. is completed on August 8, 2011, giving the company a US-based manufacturing footprint.
The status of top 10 generic manufacturer in the US by TRx is achieved for the first time.
Supply of products in the US market from Zydus Lifesciences’ SEZ facility begins.
First ANDA approval is received from its Nesher Pharmaceuticals facility, for dextroamphetamine tablets.
The first exclusive launch, mesalamine DR tablets 800mg, is executed.
Zydus (USA) introduced a refreshed visual identity, including an updated logo and typography designed to reflect the company’s focus on innovation and quality service.
Mesalamine DR tablets 1.2gm is launched with 180-days of exclusivity.
The first transdermal product, Rivastigmine Transdermal System, secures USFDA approval.
The status of top 5 generic manufacturer in the US by TRx is achieved for the first time.
ZyVet Animal Health, a Zydus (USA) subsidiary, incorporates in New Jersey on April 9, 2019, highlighting Zydus’ expansion into the US animal health market.
Supply of products in the US market from Zydus Lifesciences’ Liva facility begins.
Nelarabine injection, Zydus (USA)’s first product with CGT exclusivity, is launched.
Zydus (USA)’s parent company, Cadila Healthcare Limited, rebrands to Zydus Lifesciences Limited.
The company’s new brand identity brings together two hearts in purple and teal colors symbolizing its commitment to science and innovation, along with care and nurturance.
Zydus (USA)’s first 505(b)(2), Zituvio® (sitagliptin) tablets, is commercialized.
Zydus (USA) launches the first AP-rated generic of methylene blue injection.
The certification of Great Place to Work is achieved for the first time in the US.
First but certainly not the last time we received this recognition.
Zydus (USA)’s first 505(b)(2) oncology product, Beizray™ (docetaxel) injection, is commercialized.
An exclusive licensing supply agreement with Formycon for a Keytruda® (pembrolizumab) biosimilar (FYB206) in the US and Canada takes place.
Zydus (USA) acquires two biologics manufacturing facilities from Agenus Inc. through its subsidiary Zylidac Bio LLC.