Page 147 - CW E-Magazine (28-5-2024)

Pharmaceuticals

DEFECTIVE PRODUCTS
Dr. Reddy’s, Sun Pharma, Aurobindo recall

products in US

Drug makers Dr. Reddy’s Laborato- it added. The USFDA said the drug affected lot due to “Discoloration: dotted
ries, Sun Pharma and Aurobindo Pharma maker initiated the Class I recall in the and yellow spots on tablets”, USFDA
are recalling products in the US market US on April 8 this year. stated. The company initiated the Class II
due to manufacturing issues, as per the recall on April 24 this year.
latest Enforcement Report of the US Food As per the US health regulator, a Class I
and Drug Administration (USFDA). recall pertains to defective products that can Another drug fi rm FDC Ltd. is
cause serious health problems. The USFDA recalling 3,82,104 units of Timolol
Dr. Reddy’s Laboratories is recall- said Sun Pharma is recalling 11,016 vials Maleate Ophthalmic Solution, used to
ing close to 20,000 cartons of a medi- of Amphotericin B Liposome for injection, treat glaucoma, in the US market. The
cation used to control blood phenylala- used to treat fungal infections, in the US Maharashtra-based drug fi rm is recalling
nine levels in adults and children. New market. The company’s US-based subsi- the affected lot due to “defective container”.
Jersey-based Dr. Reddy’s Laboratories, diary initiated Class II recall on April 19 this As per the USFDA, a Class II recall is
Inc., is recalling Javygtor (sapropterin year due to “out of specifi cation for assay”, initiated in a situation in which use of,
dihydrochloride) powder for oral solu- the USFDA stated. Aurobindo Pharma or exposure to, a violative product may
tion (100-mg) being a “sub-potent is recalling 13,605 bottles of Clorazepate cause temporary or medically reversible
drug”, USFDA stated. “The company is Dipotassium Tablets (3.75-mg and 7.5-mg), adverse health consequences or where the
also recalling another lot of sapropterin used to treat anxiety, in the US market. “The probability of serious adverse health con-
dihydrochloride for the same reason,” company’s US-based arm is recalling the sequences is remote.

MARKET RUMOURS
‘Carlyle, KKR lead race to buy Bharat Serums

in $2-b deal’

Global private equity (PE) fi rms and acquired the remaining stake from the Daftary emergency medicine. In FY23 it reported
asset managers such as Carlyle, Bain family. Bharat Serums is a biopharmaceu- a net profi t of Rs. 9.4-crore, compared to
Capital, KKR, Blackstone and UK’s tical leader in women’s healthcare, assisted loss year ago and revenue of Rs. 1,207-crore,
Permira are among the organisations reproductive treatment, critical care, and up 13.8 percent on year.
in the fray to buy biopharmaceuticals
company, Bharat Serums and Vaccines Cipla’s Kurkumbh unit gets one
(BSV), according to a report in the Hindu
Businessline newspaper. The deal could observation after USFDA inspection
value BSV at well over $2-bn, the report
said quoting unnamed sources. Pharma Mumbai-based Cipla said it has A routine current Good Manufac-
and healthcare products company Man- received one inspectional observation in turing Practices (cGMP) inspection
kind Pharma is also reported to be one Form 483 from the US health regulator for was conducted by the USFDA at the
of the contenders to buy BSV. its manufacturing facility at Kurkumbh company’s manufacturing facility at
in Maharashtra. As per the US Food and Kurkumbh, Maharashtra from April 29,
Private equity fi rm Advent International, Drug Administration (USFDA), Form 2024, to May 8, 2024, Cipla said in a
which owns BSV, is looking for an exit 483 is issued to a fi rm’s management regulatory fi ling.
after four years and has been in talks since at the conclusion of an inspection when
last year with pharma companies and the investigator has observed any con- The company will work closely with
PE fi rms to sell its stake. It had originally ditions that may constitute violations of the USFDA and is committed to address-
acquired a 74 percent stake in the fi rm in the Food Drug and Cosmetic (FD&C) ing this observation comprehensively
2019 valuing BSV at $500-mn and then later Act and related Acts. within the stipulated time, Cipla said.

Chemical Weekly May 28, 2024 147

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