Page 137 - CW E-Magazine (13-5-2025)

Pharmaceuticals Pharmaceuticals

EXPANDING FOOTPRINT CLARIFICATION

BDR Pharmaceuticals eyes manufacturing assets in US Relief for pharma fi rms as Delhi High Court says

Mumbai-based BDR Pharmaceuticals accruals. BDR Pharma has a signifi cant Indian pharma companies like Dr. Reddy’s, cough syrup ban applies prospectively
is looking to expand its US footprint portion of its business contributed from Sun Pharma, Cipla, Zydus, and Torrent,
through buyouts of manufacturing faci- value-added CDMO operations focusing is evaluating 200 ANDAs in the US. In a relief to pharma companies, be prescribed/administered to children strued as an advertisement and would
lities with an investment of $100-mn, on key therapeutic segments such as These include solid dosage and inject- the Delhi High Court has held that the below four years of age. Additionally, not amount to any breach of their drug
according to its Chairman & Managing oncology, critical care, women’s health- ables in cardiology, diabetology, pain government’s April 15 notifi cation that the judges asked the manufacturers to license conditions. If the pharma com-
Director Mr. Dharmesh Shah. The com- care and dermatology. management, dermatology and HIV. prohibited the manufacture, sale, and publish an “unambiguously worded no- panies abide by the conditions regarding
pany, which has current revenue of “Around 45% or 80-90 of these ANDAs distribution of all fi xed-dose combina- tice” in two national newspapers – one the notice, advisory, and undertakings,
approximately $200-mn, is planning to “We want to manufacture certain are going to be commercialised,” said tions (certain cough syrup brands) for in English and one in Hindi – having irrespective of the manufacture and
list by 2027, he said in an interview with controlled substances and complex mole- Mr. Shah. those below four years of age will apply nationwide circulation. sale of the drug in question, no coercive
the Economic Times. cules in the US. The reason being that in prospectively. measures against them will be taken,
the US, if you have to cater to the defence The company, which is now globally The size of the notices must be de- the court said.
“We are eyeing asset acquisition for sector, the preference is for local produ- into oncology molecule, is also in the The notifi cation issued by the Mini- signed to attract the attention of readers,
manufacturing in the US. We have eva- cers,” said Mr. Shah. “We prefer that we process of setting up a new plant for com- stry of Health and Welfare, which came the court said. The notice and advisory The directions came on a couple of
luated a couple of units and we should have an establishment there and we do plex oncological injectable at Halol near into effect immediately on the said date, shall be published within a week, the appeals fi led by Glenmark and Zuventus
be deciding on the acquisition in the next the tech transfer and manufacture there Vadodara in Gujarat, where it already has mandated a manufacturer to include a court said. challenging the validity of the April 15
three to four months,” he was quoted as and cater locally to the government.” two facilities for complex injectable and warning stating ‘fi xed-dose combination notifi cation issued by the Department
saying in the report. The planned acqui- oral solid dosage in areas such as anti- shall not be used in children below four However, the manufacturers have of Health and Welfare that prohibited
sition will be funded through internal BDR, which has tie-ups with top infl ammatory, antibiotics and others. years of age’ on the label and package been directed to “compulsorily comply” the use of all formulations of the fi xed
insert or promotional literature of the drug. with the notifi cation by mentioning the dose combination of chlorpheniramine
UNSAFE DRUG warning on all their labels and packag- maleate plus phenylephrine hydrochlo-

Ranitidine ban deferred despite cancer concerns A Division Bench led by Chief Justice ing of all stocks manufactured and ride in children below four years of age.
DK Upadhaya accepted the concerns circulated after April 15.
Despite concerns over presence of run laboratory. Of the 42 Ranitidine sam- some of the samples in India exceeding of the manufacturers that the notifi ca- The restrictions issued under Section
cancer-causing agents in popular antacid ples tested at the Central Drug Laboratory the safety limit, the expert committee tion cannot applied retrospectively as The pharma companies must fi le an 26A of the Drugs and Cosmetics Act,
Ranitidine and a recent recommendation in Kolkata, 21 were found to contain recommended for the “suspension of the some stocks have been manufactured affi davit furnishing details of the stocks 1940 were imposed on the recommen-
by an expert panel for suspension of the NDMA impurities exceeding 0.32-ppm. drug Ranitidine for manufacture, sale and and were in the market before the ban manufactured, sold or have been in dations of the Drugs Technical Advisory,
drug, India’s top drug advisory body has This level surpasses the globally accept- distribution in the country,” it said. The came into effect on April 15. However, circulation before April 15, the court said. citing safety concerns. The prohibited
decided to ignore and form another “larger able limit for the impurity, which is linked committee also recommended that the the court asked the companies to issue fi xed drug combination is a commonly
committee” to look into all aspects of the to an increased risk of cancer over a life- people taking Ranitidine should consult an advisory to doctors, chemists and However, the court clarifi ed that used formulation found in various
drug. It is widely sold in India under brand time. After evaluating the global regula- their health care professional for other retailers that fi xed dose combination of any such public notice published by the over-the-counter drugs used to treat
names like Aciloc, Rantac and Zinetac. tory status of the drug and having found treatment options. drugs shall not in “any circumstances” pharma companies should not be con- colds and allergies.

After a recent meeting, the Drugs Biocon Biologics secures multiple market Zydus Lifesciences gets USFDA nod for generic
Technical Advisory Body (DTAB) also
recommended that the Indian Council of access agreements in US for ‘Yesintek’ cholesterol lowering drug
Medical Research (ICMR) should conduct Biocon has announced that its arm in the US,” Biocon said in a regulatory
a study to assess the safety of the drug. Biocon Biologics Ltd. has secured multi- fi ling. “Yesintek represents an important Zydus Lifesciences Ltd. said it has will be produced at the group’s manu- indicated to reduce the risk of recurrent
The drug was withdrawn/suspended by ple market access agreements in the US milestone for Biocon Biologics, as this received fi nal approval from the US facturing site at Moraiya, Ahmedabad, myocardial infarction in patients with
regulatory bodies including the USFDA, for its biosimilar, Yesintek, that has been is the fi rst product we have launched in health regulator to manufacture the the company informed. a history of myocardial infarction and
European Medicines Agency (EMA), and approved for the treatment of Crohn’s the US as a fully integrated biosimilars generic version of cholesterol lowering hyperlipidaemia and to reduce TG
Australia among others. disease, ulcerative colitis, plaque psoriasis company,” Biocon Biologics CEO & Niacin extended-release tablets. The Niacin is indicated to reduce ele- (triglyceride) in adult patients with
and psoriatic arthritis. Managing Director Mr. Shreehas Tambe approval by the US Food and Drug vated total cholesterol (TC), LDL severe hypertriglyceridemia.
Last year a committee was constituted said. “The listing of Yesintek on multi- Administration (USFDA) is for Niacin cholesterol (LDL-C), apolipoprotein B
to examine the safety issue of Ranitidine Yesintek (ustekinumab-kfce), is bio- ple formularies is another validation that extended-release tablets of strengths (Apo B), and triglycerides (TG), and to Citing IQVIA MAT February
in the light of the nitrosodimethylamine similar to Stelara (ustekinumab). “The payors in the US are committed to broaden 500-mg, 750-mg, and 1,000-mg, Zydus increase HDL cholesterol (HDL-C) in (2025) data, the company said the
(NDMA) impurity. The experts got sam- market access agreements from nume- access to affordable treatment options,” Lifesciences said in a regulatory fi ling. patients with primary hyperlipidaemia niacin-extended-release tablets had
ples of Ranitidine tested at a government rous plans represent over 100-million lives he added. The Niacin-extended-release tablets and mixed dyslipidaemia. It is also annual sales of $5.5-mn in the US.

136 Chemical Weekly May 13, 2025 Chemical Weekly May 13, 2025 137

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