Page 153 - CW E-Magazine (19-9-2023)

Pharmaceuticals

QUALITY ISSUES

Abbott to reinforce ‘Digene Gel’ supply after Goa

plant recall move

Healthcare major Abbott said its current demands,” a spokesperson for also alerted to watch for stocks of the
Baddi plant (Himachal Pradesh) would the company said. said product. Company representatives
supply additional stocks of the antacid said, they were working with local regu-
‘Digene Gel’, following a recent recall Following the complaint made in early latory authorities to identify and remedy
of the product made at its Goa plant. August, all batches of ‘Digene Gel’ made the problem.
at the Goa facility, were recalled, accord-
Abbott had voluntarily recalled ing to an alert from the Drug Controller In April, Abbot had initiated a vol-
‘Digene Gel’ made at its Goa facility General of India (DCGI). untary recall on a mislabelled batch
“due to isolated customers’ com- of thyroid medicine ‘Thyronorm’, in
plaints on taste and odour”. “There The company has advised doctors Madhya Pradesh and Telangana. In this
have been no reports of patient health to educate patients and to watch out case, the company had said, “The incor-
concerns. Other forms of ‘Digene’, for and report possible adverse events, rect labelling was due to a human error
such as tablets and stick packs are not linked to the product. Distributors and by one of the third-party manufacturer
impacted and ‘Digene Gel’ manufac- wholesalers have been asked to remove plant operators, we are in the process
tured at our other production site is the product, if it was made in Goa and of conducting an exhaustive investiga-
not affected and continues to be avail- still had a shelf life. The drug regula- tion at the site, and will take corrective
able in suffi cient quantities to meet tory authority around the country was actions as required.”

Dr. Reddy’s clarifi es on reported interest in Cipla

Hyderabad-based drugmaker, Dr. In a clarifi cation to the stock ex- as-usual at Cipla, which inked a deal
Reddy’s Laboratories (DRL), has dec- change, DRL said it would not com- to acquire South Africa’s Actor Hold-
lined to comment on market specula- ment on market speculation and “there ings (Pty.) Ltd. for $48.6-mn (about
tion that it was in the fray for a stake is currently no such event or informa- Rs. 402-crore). The move strengthened
in Cipla. tion which requires a disclosure under Cipla’s over-the-counter (OTC) products
Regulation 30 of the SEBI Listing portfolio in the region.
DRL is the second domestic player Regulations”. It was responding to
cited in relation to Cipla promoters’ a report that private equity (PE) fi rm Cipla doyen Dr. Y. K. Hamied had
reported plans to sell their stake in the Bain Capital had approached DRL for recently told shareholders that reports
company. Earlier, Gujarat-based Tor- a joint bid for the promoters’ stake in on the family’s exit were “speculative”.
rent Pharma was said to have shown Cipla. However, in the absence of an outright
interest, including cobbling together a denial, reports continue to emerge on
consortium to make its bid. Meanwhile, it appeared to business- PE bids.

Natco Pharma, others sued in US for generic cancer

drug

Natco Pharma said the company and ridge Pharmaceutical Inc. and others have believes this matter is without merit,
other drug makers have been named been named defendants by Louisiana Natco Pharma said in a statement.
defendants in an antitrust lawsuit Health Service & Indemnity Company,
regarding a generic cancer treatment D/B/A Blue Cross and Blue Shield of Breckenridge is the abbreviated
drug in the US. The Hyderabad-based Louisiana and HMO Louisiana Inc., new drug application (ANDA) holder
drug fi rm along with Celgene Corpo- regarding anti-cancer treatment medi- and distribution partner for the generic
ration, Bristol Myers Squibb, Brecken- cation ‘Pomalidomide’. The company product in the US, it added.

Chemical Weekly September 19, 2023 153

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