Page 153 - CW E-Magazine (30-4-2024)

Pharmaceuticals

REGULATORY ACTION
Jubilant Pharma gets VAI classifi cation from USFDA

for Roorkee unit

Jubilant Pharma said the US health “Based on this inspection and the Over the last few years, the US
regulator has decided that the inspection USFDA VAI classifi cation, the facility generics market has been witnessing
classifi cation of its subsidiary’s Roorkee- is considered to be in acceptable state of signifi cant pricing pressure leading to
based plant is voluntary action indicated compliance with regard to current good signifi cant losses at Jubilant Cadista
(VAI). manufacturing practices (cGMP),” it added. since FY2022 onwards. In order to
With this, the FDA has concluded that move the US generics business to
Jubilant Pharmova, a wholly-owned this inspection is closed, Jubilant Pharma profi tability, the company decided to
subsidiary of the company, has received said. change the operating model from in-
a communication from the US Food and house manufacturing to outsourced
Drug Administration (USFDA) that the US subsidiary ceasing manufacturing manufacturing by selected USFDA
facility has been classifi ed as VAI pursuant In another development, Jubilant approved CMOs for the US market.
to inspection from January 25 to Febru- Pharma informed that its subsidiary, Further, the company expects the
ary 2, 2024, it said in a regulatory fi ling. Jubilant Cadista Pharmaceuticals Inc., exports from the Roorkee facility to
USA, has decided to close the manufac- the US market to increase gradually.
As per the USFDA, a VAI inspection turing operations of its solid dosage for- As of now the facility, was exporting
classifi cation indicates that although mulation facility at Salisbury, Maryland, only one product, Risperidone to the
investigators found and documented USA. The expected date of cessation of US market.
objectionable conditions during the inspec- manufacturing operation and fi rst sepa-
tion, FDA will not take or recommend rations at the facility will be on 17 June Jubilant Cadista said it will con-
regulatory or enforcement action because 2024. However, Jubilant Cadista will tinue to explore various options to
the objectionable conditions do not meet continue the sales and marketing opera- utilise or sell the Salisbury facility’s
the threshold for action at this time. tions for US market. land, building and plant & machinery.

SIMILAR BRAND NAMES
Delhi High Court upholds injunction against Glenmark

Pharma

In a major respite to Sun Pharma Sharma, dismissed Glenmark’s appeal The case
Laboratories Ltd., the Delhi High Court and lifted the order keeping the injunction The case involved Sun Pharma alleg-
has upheld its previous ruling from July, on hold. The bench supported the single ing trademark infringement and passing
affi rming the injunction against Glenmark judge’s decision, stating that the dom- off against Glenmark for its use of the
Pharmaceuticals. inant features of the competing marks mark ‘Indamet’. Sun Pharma claimed
are ‘Indamet’ and ‘Istamet’. The court rights to the mark ‘Istamet’ used for
The injunction restrains Glenmark emphasised that the removal of ‘XR’ and diabetes treatment. Despite ongoing pro-
from manufacturing, selling, or adverti- ‘CP’ from consideration does not alter ceedings before the Trademark Regis-
sing its asthma medication under the this assessment, as Sun Pharma does not try, Glenmark launched ‘Indamet’ for
name ‘Indamet’ or any similar mark to claim exclusive rights to these suffi xes. uncontrolled asthma treatment, arguing
Sun Pharma Laboratories’ registered distinctions in product usage and packag-
mark for its anti-diabetes drug ‘Istamet The court noted that ‘Istamet’ has ing to avoid confusion. Sun Pharma and
XR CP’ until the case concludes. been available since 2011, whereas Glenmark contested their rights to use
Glenmark launched its product in June the drug names ‘Istamet’ and ‘Indamet’”
A Division Bench, comprising jus- 2022, following opposition from Sun respectively, which Sun Pharma found to
tices Yashwant Varma and Dharmesh Pharma in May 2022. be deceptively similar and confusing.

Chemical Weekly April 30, 2024 153

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