Page 146 - CW E-Magazine (28-11-2023)

Pharmaceuticals Pharmaceuticals

REGULATORY INSPECTION Businesses, the limited letter of intent chain lengths is becoming more rele- based on market opportunities, thereby,
that Auronbindo signed with the MSD vant than ever,” he said. reducing the gestation period, he added.
Cipla receives US FDA warning over manufacturing entity allows it to create infrastructure
for contract manufacturing of innovator The biologics contract manufactur- In the second quarter ended
practices at Pithampur plant biologics. The market for originator ing industry is growing immensely and September 30, 2023, Aurobindo regis-
biologics right now is about $300-bn to is poised to grow to about $30-bn to tered revenue of Rs. 7,219-crore, a 26
Pharma major Cipla has received a uphold quality and compliance with Completes stake sale in Uganda’s $350-bn. “With more biologics appro- $40-bn by 2030, he noted. Aurobindo percent increase, compared to the same
warning letter from the US FDA for the utmost importance and remain com- CQCIL vals and their success in treating debili- will continue to explore opportunities quarter last year. Net profi t increased
routine current Good Manufacturing mitted to be compliant with the cGMP In another development, Cipla has tating diseases worldwide, the need for for any bolt-on acquisition aligned by 83.6 percent year-on-year and by
Practices (cGMP) inspection conducted quality standards,” it said. announced that Cipla Quality Chemical reliable manufacturing, improving lead with its strategy, especially acquisition 31.7 percent quarter-on-quarter, to
at its Pithampur manufacturing facility Industries Ltd. (CQCIL) has ceased to time effi ciencies, and reducing supply of ANDAs and market authorisation Rs. 752-crore.
from February 6-17, 2023. This warn- Earlier, the management had said be its subsidiary, following the com-
ing letter summarises contraventions that the US FDA observations at Cipla’s pletion of its stake sale in the Ugandan EVENT HIGHLIGHTS
regarding methods or controls followed plants in Pithampur and Goa were company. In a statement, Cipla said its
at the facility which do not conform to delaying the launch of products by wholly-owned subsidiaries Cipla (EU) CPHI & PMEC India Expo to begin from November 28
the prescribed cGMP regulations and almost six months in its Q2 press meet. Ltd. (UK) and Meditab Holdings Ltd.
contains directional guidance for nece- The management had then said that (Mauritius) completed the sale of their The 16th edition of CPHI & PMEC hospital administrators, as well as ‘Pre-Connect Congress’, a one-day gathe-
ssary corrections. the biggest product manufactured at 51.18% stake in CQCIL (Uganda) for a India Expo will be held from Novem- representatives from national and state ring featuring around 20 speakers mak-
the Pithampur facility was Advair and consideration amount of $25-mn. “Ac- ber 28-30, 2023, at the India Expo regulatory boards and policymakers. ing presentation on issues ranging from
The plant was issued eight observa- that they were in the process of shift- cordingly, CQCIL has now ceased to be Centre, Greater Noida, Delhi. The Notable exhibitors at the event include smart manufacturing and innovations
tions by the US drug regulator for the ing its manufacturing to Hauppauge in a subsidiary of the company with effect event is expected to bring together over Dr. Reddy’s Laboratories, Biocon, in pharmaceutical R&D to strategies
inspection carried out earlier this year. Long Island. Advair, which is used in from 14th November, 2023,” it added. 45,000 visitors and 1,500 exhibitors Glenmark Lifesciences, Hetero Labs, for enhancing innovation. The ‘Pharma
In August, the facility was classifi ed as the treatment of asthma and chronic Quality Chemicals was incorporated in from around 150 countries. ACG, Lee Pharma, Unilab Chemicals Leaders Roundtable’, ‘Women in Pharma’
Offi cial Action Indicated (OAI). The obstructive pulmonary disease, is expec- 1997 and was involved with the import and Pharmaceuticals, and many others. and ‘Pharma Talks’ are the other high-
company will respond to the Warning ted to have signifi cant revenue poten- and distribution of pharmaceutical and According to the event organiser, light of the ‘India Pharma Week’. The
Letter within the stipulated timelines tial, with analysts expecting it to bolster consumer products. Cipla had undertaken Informa Markets, the event is expected to The CPHI & PMEC India Expo in- event will also witness the 10th edition
and work closely with the US FDA to Cipla’s fi nancials. The drug commands the transaction in 2015 to strengthen its provide a platform to engage with pharma- cludes the ‘India Pharma Week’, a series of the ‘India Pharma Awards’ cele-
address the concerns, Cipla said. “We an annual market size of $700-mn. presence in the African market. ceutical executives, buyers, procure- of exclusive events. These events in- brating excellence and innovation within
ment managers, contract manufacturers, clude the ‘Pharma Leaders Golf’ and the the pharmaceutical space.
GROWTH ENABLERS
Aurobindo Pharma’s China plant gets EU’s GMP SCIENCE EDUCATION

approval CSIR-CDRI and RSC organise teacher training programme
Hyderabad-based Aurobindo Pharma’s European dispatches, because it takes and stabilisation of manufacturing pro- The CSIR-Central Drugs Research appealing and easily understandable learning tools such as Show Me Board,
China plant has received the “quite a lot of time’’ to get approval cesses, the company expects the base Institute (CSIR-CDRI), Lucknow, in teaching methods was emphasised to Flashcards, and Word walls, enabling
European Union’s Good Manufactur- from Chinese regulators, he added. EBITDA margin to improve, consider- collaboration with the Royal Society of facilitate effective learning experiences. teachers to create dynamic and inter-
ing Practices (GMP) approval. ing the current market conditions. Chemistry (RSC), UK (Indian Chapter), active learning environments that foster
“The other plants, the Pen-G plant successfully conducted a two-day On the fi rst day of the programme, understanding and engagement. Ms.
“The China plant is fully installed and the 6-APA plant, are under installa- Focus on biosimilars teacher training workshop aimed at Ms. Karima Anjum, resource person Anjum also demonstrated various AI-powe-
and has received EU’s GMP approval. tion and are expected to be operational “This margin is without consider- elevating the teaching methodologies of from the RSC, shed light on the signi- red tools that educators could employ to
It is expected to start revenue genera- from Q4 FY24 or Q1 FY25,” he said in ing the margin for biosimilars. We are science educators. The event took place fi cance of these workshops, which create captivating classrooms. The tools
tion from the end of the fourth quarter an earnings call. “Further, we are con- strongly focused on biosimilars and at CSIR-CDRI Auditorium Hall and were conducted under the banner of the showcased included Word walls, Google
of FY24 or early in the fi rst quarter ducting clinical studies for our biosi- peptides, and these are signifi cant levers witnessed the participation of over 40 Dr. Yusuf Hamied Inspirational Science Sheets, Flippity, Tarsia maker, Padlet,
of FY25,” informed Mr. Santhanam milar products and the plant is expected for the future,” the CFO said. Strategic educators from different schools. The Programme (YHISP). This initiative envi- and Jamboard. She illustrated how these
Subramanian, CFO, Aurobindo Pharma. to be commissioned by FY25 or early partnerships like Merck, announced primary objective of the workshop was sions the enhancement of science educa- tools could be seamlessly integrated into
FY26,” he noted. recently by the company, would continue to empower science teachers with inno- tors’ skills and knowledge, focusing on science lessons, facilitating interactive
The company is in the process of to fuel growth and margins beyond vative techniques that make the process equipping them with novel techniques activities and question-based learning.
manufacturing the exhibit batches and With these initiatives, including FY25, he added. According to Dr. of teaching not only more comprehen- to effectively deliver and elucidate com- Participants were also shown how to
plans to fi le around fi ve products from commercialisation of the Pen-G plant Satakarni Makkapati, CEO of Aurobindo sible, but also engaging and captivating plex scientifi c concepts. She introduced conduct microscale experiments using
the China plant, and to start with the and other projects over a period of time Biosimilars, Vaccines and Peptide for students. The integration of visually participants to a range of innovative simple and low-cost objects.

146 Chemical Weekly November 28, 2023 Chemical Weekly November 28, 2023 147

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