Page 150 - CW E-Magazine (20-5-2025)

Top Stories Pharmaceuticals

ALTERNATIVE ENERGY GEARED FOR GROWTH
Private sector is interested in India’s nuclear energy Piramal Pharma plans $90-mn expansion of two US sites

push, but policy gap remains: Report Piramal Pharma, in conjunction with

the 2025 SelectUSA Investment Summit,
India’s ambitious plan to achieve The government has taken an im- on private companies remains high at has committed to a $90-mn investment
100-GW of nuclear power capacity by portant step by launching the BSR various stages of development. plan towards brownfi eld expansions of
2047 has begun to draw strong interest (Bharatiya Saksham Reactor) pro- two of the company’s US facilities.
from the private sector but to ensure gramme. This allows the private sector The report stated that a critical im-
that it contributes to at least 50 percent to develop Pressurised Heavy Water provement would be the inclusion of a The expansions, to be fi nanced by
of this target, existing policy gaps need Reactors (PHWRs) for captive use. compensation clause to protect private bank loans and internal accruals, are in
to be addressed quickly, according to a players if the Department of Atomic response to ongoing demand from US commercial-scale suite specifi cally for the CEO, Global Pharma. “The US is our
report by SBI Capital Market. The report added that the pro- Energy fails to supply adequate fuel and customers and in support of the trend development and manufacturing of pay- largest market, where we currently
gramme comes with strict entry cri- heavy water. Transparent pricing mecha- towards US onshoring of drug supply, the load-linkers. These high potency APIs are employ approximately 750 people. Expand-
The report also mentioned that the teria to ensure that only serious and nisms are also necessary. Moreover, there company informed. Piramal Pharma’s used in the development of antibody-drug ing the capacities and off erings in these
opportunity is not limited to just project capable players participate, which also should be clear guidelines on the alloca- Lexington, Kentucky, facility specialises conjugates (ADCs) and other bioconjugate two plants in the US, along with the pri-
development. A wide range of compa- helps reduce risks related to imple- tion of extra costs, such as those related in sterile compounding, liquid fi lling, and drugs. The new payload-linker suite is or major investments made in our Sell-
nies can benefi t across the nuclear power mentation and funding. The captive to power transmission. Incentives for lyophilization for sterile injectable drug expected to be operational before the end of ersville PA drug product facility, and our
ecosystem. This includes reactor manu- use model is another positive aspect, State Governments to approve such pro- products. The site’s expansion – which 2025. These site expansions are expected inhalation anesthesia drug substance and
facturers, turbine and generator supp- as it reduces demand uncertainty. jects would help speed up approvals. Bet- includes 24,000 square feet of manu- to generate greater opportunities for inte- drug product facility in Bethlehem PA,
liers, precision control and equipment Despite these encouraging steps, more ter force majeure and termination clauses facturing space and a new laboratory – grated ADC projects. Working synergisti- will support our customers who value our
providers, and specialists in cooling needs to be done to make the BSR would give more security to investors. adds commercial-scale manufacturing cally, they will play a vital role in Piramal off erings in an onshore setting,” he added.
systems. “The potential is clear – what programme fully eff ective. Currently, the Lastly, off ering sovereign support and that will enable the effi cient scale-up of Pharma’s integrated ADC development The company said the expansions bring
remains uncertain is whether the right approval process is too long and fol- tax liability waivers when the plant is clients’ injectable drug products. Key and manufacturing programme, branded commercial-scale support to two important
policy “triggers” will be introduced to lows a sequential path, slowing down transferred to NPCIL could improve the additions include a new fi lling line, two ADCelerate. With development and com- and fast-growing segments of drug deve-
set the sector in motion,” it stated. progress. In addition, the risk burden programme’s overall success. commercial-size lyophilisers, a special mercial-scale capabilities in mABs, pay- lopment. Payload-linkers are fundamental
capping machine, and an external vial load-linkers, conjugations, and fi ll/fi nish, to the process of building bioconjugates,
CARBON-FREE ENERGY washer. The facility is expected to be ADCelerate speeds timelines, enabling which are the platform for numerous
completed and online by late 2027.
project initiation to GMP drug product in oncology drugs. Sterile fill/finish
Coal India to set up 4.5-GW renewable energy The second site at Riverview, Michigan just 12 months. represents the fi nal stage of manufacturing
for injectable drugs. Collectively, these
projects for AM Green’s ammonia facilities site, is involved in the development and “Since its inception, Piramal Pharma expansions support our integrated drug
manufacturing of active pharmaceutical Ltd. has invested $570-million in its US development and manufacturing services
Coal India Ltd. (CIL) is planning to (supply of renewable power) would sunny States like Gujarat and Rajasthan. ingredients (APIs) and high potency APIs drug development and manufacturing and will ultimately get more treatments
set up 4.5-GW renewable energy pro- be through a combination of solar and AM Green will integrate the two renew- (HPAPIs). Here, the company is adding a capabilities,” said Mr. Peter DeYoung, into patients on faster timelines.
jects in a phased manner at an estimated wind whose capacities CIL aims to able sources supplied by CIL with pumped
total outlay of around Rs. 25,000-crore set up on pan India basis. This initia- hydro storage to ensure a steady supply of FDC recalls over 60,000 bottles of ophthalmic
for supplying carbon-free energy to tive aligns with India’s national goal green energy to AM Green facilities.
upcoming green ammonia facilities of of achieving a cleaner energy mix and solution in US
AM Green in Gujarat’s Kandla or any transition towards net-zero emissions.” The formal non-binding MoU for
other facility. long-term supply and sourcing of re- Drug fi rm FDC Ltd. is recalling over was lodged in the nozzle of the product
While the solar power capacity newable energy was inked in Kolkata 60,000 bottles of a generic medication, used bottle,” the USFDA said.
AM Green, promoted by founders would be to the tune of 2,500-MW to recently. to treat glaucoma, in the US market due to
of Hyderabad-based Greenko Group, 3,000-MW, wind is expected to account manufacturing issue, according to the US The drugmaker initiated the Class II
is among India’s leading renewable between 1,500-MW and 2,000-MW at AM Green targets to produce 5-million health regulator. As per the latest Enforce- nationwide (US) recall on April 18 this year.
As per the USFDA, a Class II recall is
ment Report by Food and Drug Adminis-
energy conglomerates. CIL and AM Green an estimated total outlay of around tons per annum (mtpa) of green tration (USFDA), the Mumbai-based fi rm is initiated in a situation in which the use of, or
Ammonia (India) have executed a non- Rs. 25,000-crore, CIL informed. ammonia by 2030. This equals to ap- recalling 60,428 bottles of Timolol Maleate exposure to, a violative product may cause
binding Memorandum of Understanding proximately 1-mtpa of green hydrogen Ophthalmic Solution in the US market. The temporary or medically reversible adverse
(MoU). It would be one of the world’s Potential sites for wind projects will and represents a fi fth of India’s target company is recalling the aff ected lot due to health consequences or where the probabi-
largest renewable energy contracts. In be explored in the southern States of the for green hydrogen production under the “Defective container: Unable to get the solu- lity of serious adverse health consequences
a stock exchange fi ling, CIL said, “It county. And, solar plants will be in the National Green Hydrogen Mission. tion out of the bottle as the spike of the cap is remote.

150 Chemical Weekly May 20, 2025 Chemical Weekly May 20, 2025 151

Contents Index to Advertisers Index to Products Advertised