Zydus Lifesciences Moraiya facility earns USFDA EIR approval

Zydus Lifesciences Moraiya facility earns USFDA EIR approval

In a remarkable stride toward global pharmaceutical excellence, Zydus Lifesciences Ltd has proudly secured the prestigious Establishment Inspection Report (EIR) endorsement from the United States Food and Drug Administration (USFDA). This noteworthy achievement was granted to their state-of-the-art facility located in Pharmez, Ahmedabad, which remarkably received an impeccable inspection report with zero observations.

The facility, aptly designated as ‘SEZ 2’, underwent a meticulous inspection process from July 3 to July 7, as disclosed in the official communication to the stock exchanges on Tuesday, September 19. It’s noteworthy that this inspection was a Pre-Approval Inspection (PAI), concluding with a resounding endorsement of nil observations, as confirmed by Zydus Lifesciences.

This announcement follows the closure of the USFDA inspection at Zydus Lifesciences’ Pharmez unit in Ahmedabad in July, which garnered a recommendation of Voluntary Action Indicated (VAI) in the EIR. The USFDA conducted the comprehensive inspection at the unit between March 20 and March 24, 2023.

In yet another stride, Zydus Lifesciences secured final approval from the USFDA for Norelgestromin and Ethinyl Estradiol Transdermal System, an innovative contraceptive patch comprising a combination of hormone medication. This significant development transpired just last week.

Moreover, the pharmaceutical powerhouse had previously received final USFDA approval for Isotretinoin Tablets, a vital component in the treatment of severe cystic acne, last month. In addition to this, it has been granted the final green light from the USFDA for the manufacturing and marketing of Indomethacin suppositories, used in the treatment of arthritis.

Based in Ahmedabad, this pharmaceutical giant has established its footprint in the industry by manufacturing and marketing a diverse array of active pharmaceutical ingredients (API) and formulations.

The Zydus group, headquartered in Ahmedabad, boasts an extensive network of research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim. Their global reach extends beyond India, encompassing manufacturing and research units in the United States and Brazil, with licensing agreements in place with esteemed multinational corporations.

About Zydus Lifesciences:

Zydus Lifesciences Limited, previously recognized as Cadila Healthcare Limited, stands as a prominent Indian multinational pharmaceutical corporation with its headquarters situated in Ahmedabad. The company’s primary focus lies in the production of generic medications. In the year 2020, Zydus Lifesciences Limited secured the 100th position in the Fortune India 500 list.

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