Page 145 - CW E-Magazine (27-8-2024)

Pharmaceuticals

FINANCIAL PERFORMANCE
Gland Pharma’s Q1 net profi t drops

Gland Pharma’s consolidated Biologics facility early stages, it represents promising
net profi t declined 26 percent to The company said its biologics avenues for Gland to maximise its value
Rs. 143.8-crore in the fi rst quarter ended facility in Genome Valley is attracting in both CDMO and complex portfolio
June 30 against Rs. 194-crore in the advanced-stage interest from multiple expansion,” he said. During the quarter,
corresponding quarter of the previous players for contract manufacturing of Glad Pharma launched eight molecules,
fi nancial year. monoclonal antibodies and novel plasma- including Eribulin mesylate, Plerixafor,
based proteins. Nelarabine, and Edaravone in the US
The revenue of the Hyderabad- market. It fi led nine products in China till
based company increased 16 percent to “In addition, we are in discussions date, of which three have been approved
Rs. 1,401-crore compared to Rs. 1,209-crore with a leading biologics company for a and one has been commercialised.
in the year ago period. potential strategic collaboration,” he said.
The USFDA made two surprise ins-
“The growth in revenue aligns with The proposed collaboration could pections of its manufacturing sites in
our projections and is primarily driven involve large-scale contract manufac- Hyderabad. The inspections concluded
by the US market, which saw a 27 per- turing of key biosimilars, with a possible with two and three ‘Form 483’ obser-
cent revenue increase led by existing in-licensing opportunity for Gland in vations at Dundigal and Pashamylaram,
and certain new products,” Mr. Srinivas specifi c markets of interest. respectively. The drug-maker said these
Sadu, Executive Chairman and CEO, observations were `procedural and do
Gland Pharma, said in a release. “Although this discussion is in the not affect its compliance status.

Dr. Reddy’s gets EIR from USFDA for Visakhapatnam

units

Dr. Reddy’s Laboratories Ltd. said lities (FTO-7 & FTO-9) in Duvvada, that it would address the issue within
it has received an Establishment Inspec- as Voluntary Action Indicated (VAI) the stipulated timeline.
tion Report (EIR) from the US Food and and concluded that the inspection is
Drug Administration (USFDA) for its for- “closed”, the Hyderabad-based fi rm As per the US health regulator,
mulations manufacturing units at Duvvada said in a regulatory fi ling. Form 483 is issued to a fi rm’s manage-
in Visakhapatnam, classifying the facilities ment at the conclusion of an inspection
to voluntary action indicated. Earlier, the USFDA had issued a when the investigator has observed any
Form 483 with two observations to the conditions that may constitute viola-
The USFDA has classifi ed the com- two units following an inspection in tions of the Food Drug and Cosmetic
pany’s formulations manufacturing faci- May 2024. Dr. Reddy’s had then stated (FD&C) Act and related Acts.

USFDA approves Alembic’s psoriasis drug

Alembic Pharmaceuticals has severe psoriasis in adults. According to 184 fi nal approvals and 28 tentative
announced that it has received fi nal the National Institutes of Health, reti- approvals.
approval from the US Food and Drug noids play a crucial role in regulating
Administration (FDA) for psoriasis the immune system, cellular growth, The generic is therapeutically
drug, Acitretin, in 10-mg, 17.5-mg, and differentiation. They also have equivalent to Stiefel Laboratories’
and 25-mg strengths. anti-infl ammatory effects and can ‘Soriatane’ capsules. The estimated
inhibit tumour growth. This approval market size for Acitretin capsules was
Acitretin is a retinoid medication marks Alembic’s 212th ANDA ap- $21-mn for the 12 months ending June
related to vitamin A that is used to treat proval from the USFDA, including 2024, according to IQVIA data.

Chemical Weekly August 27, 2024 145

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