Page 135 - CW E-Magazine (10-6-2025)

Pharmaceuticals Pharmaceuticals

PHARMA EDUCATION IMPORT SUBSTITUTION

Pharmaceutical Formulation Innovation Technology & TDB to fund indigenous manufacturing of complex

Engineering Centre inaugurated at SIES excipients by Nitika Pharma

Formulation engineering is the lowest pharmaceuticals market – In its continued endeavour to bolster this project into
cost innovation possibility, albeit is about $12-bn, Ireland’s India’s pharmaceutical manufacturing a signifi cant leap
with high level science input, and exports to the US are about ecosystem and reduce dependency on toward self-reliance
India’s pharmaceuticals industry as fi ve times bigger at $65-bn. imports, the Technology Development in pharma auxi-
well as academic institutions will do Board (TDB), Department of Science liary production.
well to emphasise research in this area. India’s pharmaceuticals and Technology (DST), has extended The project is
industry, he added, currently fi nancial support to Nitika Pharma- also aligned with
This was stated by Prof. M.M. Sharma, plays a volume game, but ceutical Specialties Pvt. Ltd., Nagpur, the Government of
Former Director, Institute of Chemi- must turn to value leadership, for manufacture of complex excipients. India’s Production
cal Technology (ICT), while inaugu- which needs innovation. Linked Incentive
rating the Pharmaceutical Formulation “Health issues are staggering Excipients, though pharmacolo- excipients that cater to advanced pharma- (PLI) scheme for pharmaceuticals,
Innovation Technology and Engineering in India, and collaboration gically inactive, are critical to the func- ceutical applications. These products under which Nitika Pharma has been
Centre at the SIES School of Pharma- He urged the Centre to aim at developing with academia is still poor,” he lamented, tionality, stability, and delivery of medi- will be developed in line with the Quality selected as benefi ciary.
ceutical Sciences, in Mumbai on a formulation that will go to industry in noting that the area of biologicals is still cines. As drug formulations become by Design (QbD) framework, ensuring
May 24. The state-of-the-art centre has two years. “SIES should target becom- a weakness in India. “China has invested increasingly sophisticated – with rise of precision in parameters like surface “India’s pharmaceutical strength
complex generics, biopharmaceuticals, area, particle size, and stability to meet must be matched with domestic resili-
been made possible by generous sup- ing a leading institute on pharmaceutical heavily in biologicals.” and novel delivery systems – demand for international standards. ence in critical inputs like excipients.
port of EncubeEthicals Ltd., a leading research in the next ten years.” high-quality, tailor-made excipients has TDB is pleased to support Nitika’s
pharmaceuticals company, and boasts Catalyst for training surged. India, despite being a pharma- Established in 1991 and later incor- forward-looking project that strengthens
of modern equipment for the benefi t of From volume to value Mr. K.G. Ananthakrishnan, Former ceutical powerhouse, continues to porated as a Private Limited Company India’s position not just as a pharmacy
students pursuing their B.Pharm and Mr. Mehul Shah, Managing Direc- Managing Director, Merck Sharpe and import the bulk of these complex exci- in 2011, Nitika has evolved into a trusted of the world, but also as a maker of
D.Pharm courses the School. tor & CEO, EncubeEthicals, pointed to Dohme Ltd., observed that the newly pients from countries like the US, China, global supplier of fi ne chemicals and world-class excipients. This initiative
the high growth potential in the Indian created state-of-the-art laboratory will and France. Through this project, Nitika specialty excipients. With a DSIR-recog- will boost both Atmanirbhar Bharat
“There is a high-level engineering in pharmaceutical industry. In his view, serve as a catalyst to train a new breed Pharma aims to establish a state-of-the- nized in-house R&D facility and a and India’s capacity to support global
formulations today in several industries the Indian industry which is currently of students with practical and theoretical art manufacturing facility for commer- global footprint across 90 countries, the health,” said Rajesh Kumar Pathak,
including pharmaceuticals, fl avours and valued at $60-bn, is expected to reach knowledge. “India needs delivery of cial-scale production of 14 complex company is well-positioned to translate Secretary, TDB.
fragrances, etc. Every drug, for example, a size of $500-bn by 2027, at an annual formulations that are of high quality and
is a formulated product, andfor paedia- average growth rate of 9%. While the world class,” he stated, while urging REGULATORY SCRUTINY
tric drugs the science of microemulsions industry takes pride in the fact that students to immerse themselves in learning
very important,” Prof. Sharma observed. exports to the US – the world’s largest and strive relentlessly for excellence. USFDA completes inspection at Piramal Pharma

MILESTONE Canada facility

Sun Pharma completes acquisition of Checkpoint Piramal Pharma Ltd. (PPL) has conditions that in their judgment may Hospital Generics business, and the
announced that the USFDA has success- constitute violations of the Food Drug India Consumer Healthcare business
Therapeutics fully completed a GMP (Good Manu- and Cosmetic (FD&C) Act and related selling over-the-counter products.
facturing Practices) Inspection at the Acts.
Sun Pharmaceutical Industries Ltd. “This acquisition exemplifi es Sun Sun Pharma has acquired all out- company’s facility at Aurora, Canada PPS offers end-to-end development
has announced the successful comple- Pharma’s commitment to supporting standing shares of Checkpoint at a price with Zero Form-483 observations and PPL offers a portfolio of differen- and manufacturing solutions through a
tion of its acquisition of Checkpoint patients and growing its innovative of $4.10 per share in cash, without inte- No Action Indicated (NAI) designation. tiated products and services through end- globally integrated network of facilities
Therapeutics, Inc., an immunotherapy therapies business,” said Dilip Shanghvi, rest, plus one non-tradable contingent to-end manufacturing capabilities across across the drug life cycle to innovators
and targeted oncology company. As Chairman & Managing Director, value right (CVR) per share represent- NAI means no objectionable condi- 15 global facilities and a global distri- and generic companies. PCC’s complex
part of the acquisition, Sun Pharma Sun Pharma. “By adding Unloxcyt, we ing the right to receive up to an addi- tions or practices were found during bution network in over 100 countries. hospital product portfolio includes inha-
acquires Unloxcyt, the fi rst and only will be able to leverage our leadership tional $0.70 in cash, without interest, if the inspection, held from May 26-30. PPL includes Piramal Pharma Solutions lation anaesthetics, intrathecal therapies
FDA-approved anti-PD-L1 treatment in the onco-derm space to help patients certain specifi ed milestones are met, as An FDA Form 483 is issued to the man- (PPS), an integrated Contract Develop- for spasticity and pain management,
for advanced cutaneous squamous cell access an important treatment option set out in the terms and conditions of agement at the conclusion of an inspec- ment and Manufacturing Organization; injectable pain and anaesthetics, injectable
carcinoma. while growing our product portfolio.” the contingent value rights agreement. tion when investigation has observed Piramal Critical Care (PCC), a Complex anti-infectives, and other therapies.

134 Chemical Weekly June 10, 2025 Chemical Weekly June 10, 2025 135

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