Page 147 - CW E-Magazine (1-10-2024)

Pharmaceuticals Pharmaceuticals

REDUCING IMPORT DEPENDENCY FULL OWNERSHIP
Aurobindo set to begin full-scale production at Aurobindo to acquire balance 49% stake in GLS

new penicillin-G plant in AP Pharma

Prime Minister Narendra Modi is plant has a capacity to produce 3,600-tpa, Aurobindo Pharma has said it its promoters for acquisition of from promoters Suresh Pathak and
likely to inaugurate antibiotic Penicil- the drug maker had earlier said in will acquire the balance 49% stake in remaining 5,90,361 equity shares of his family members on June 17,
lin-G plant (Pen-G) in Andhra Pradesh, a statement. The company said that GLS Pharma Ltd. for Rs. 22.5-crore Rs. 10 each amounting to 49% stake 2022. GLS is engaged in oncolo-
three decades after the country’s last Pen-G, glucose, 6-APA and granulated to make the latter a wholly-owned for a purchase consideration of gy products, which include orals
plant shut down. According to a report products will be for captive use, domes- subsidiary. Rs. 22.5-crore. The shares are being and injectables used in chemo-
in the Economic Times, decks have tic supply and exports, while a vials/ acquired at a price of Rs. 381.12 per therapy for solid malignancies,
been cleared for Hyderabad-based ampoules plant will be for export markets. The company entered into a share, Aurobindo Pharma said in chemotherapy for haematological
Aurobindo Pharma to begin production of binding agreement on September a regulatory filing. Aurobindo ac- malignancies and chemo-supportive
penicillin-G at their plant at Kakinada stopped producing Pen-G about three In 2021, the government initiated 18, 2024, with GLS Pharma and quired a 51% stake in GLS Pharma products.
in Andhra Pradesh. decades ago and has been dependent on a Production Linked Incentive (PLI )
China for them. scheme for boosting domestic manufac- REGULATORY ACTION
The company is said to have started turing of APIs and key starting materi- Torrent Pharma gets an observation from USFDA
producing small batches and could be- The Pen-G facility, located in a SEZ als, to encourage exports of these raw
gin full scale production of 300-tonnes at Kakinada in Andhra Pradesh, has a materials for drug makers. The scheme for Pithampur plant
towards the end of this year. Pen-G is production capacity of 15,000-tpa, while was announced for crucial fermentation
used in making several antibiotics. India the 6-Amino Penicillanic Acid (6-APA) products, including Pen-G. Torrent Pharmaceuticals has said Pithampur, Madhya Pradesh from with it to address the observation at

LEADERSHIP CHANGE that the US health regulator has issued September 16-20, the drug maker said in the earliest possible time. As per the
a Form 483 with one observation after a regulatory fi ling. “At the end of the USFDA, a Form 483 is issued to a
Dr. R.N. Gupta is new President of Indian inspecting its Pithampur-based manu- inspection, the agency issued a Form fi rm’s management at the conclusion

Pharmaceutical Association facturing facility. 483 with one observation which is pro- of an inspection when the investigator
cedural in nature,” it added. The com-
has observed any conditions that may
The USFDA conducted a routine pany said it will respond to the USFDA constitute violations of the Food Drug
Dr. R.N. Gupta has been elected who have been elected for the Hospital Pharmacy Division, GMP inspection of the company’s within the prescribed timeframe and Cosmetic (FD&C) Act and related
as the National President of the Indian term 2024-2026 are Dr. Subhash Mr. M. Vasudev Rao as Chair- formulation manufacturing plant at and will work in close collaboration Acts.
Pharmaceutical Association (IPA) for Mandal as National Honorary person – Industrial Pharmacy
2024-2026 period. General Secretary and Division and Dr. A. Ramkishan Ind Swift Laboratories opens new marketing offi ce
Dr. Alka Mukne as Honorary as Chairperson – Regulatory
Dr. Gupta, currently an Adjunct Treasurer. The elected Vice Affairs Division. Dr. Anuradha in Delhi
Professor with NIPER-Kolkata, is a Presidents include Raj Vaidya Majumdar and Dr. S. Vidyadhara
senior professional, with almost fi ve as Chairperson – Community have been elected Editors of Chandigarh-based pharma firm, hub for all operations related to the affairs. “Our goal is to create a cohe-
decades of experience in the pharma- Pharmacy Division, Dr. G. Sumalatha Pharma Times & Indian Journal Ind Swift Laboratories, has an- company’s Ethical Pharmaceutical sive and highly functional environ-
ceutical industry, academia and as Chairperson – Education Division, of Pharmaceutical Sciences (IJPS), nounced the setting up a new mar- Business, encompassing critical ment that aligns with our mission to
research. The other IPA offi ce bearers Dr. Ramesh Adepu as Chairperson – respectively. keting office in New Delhi. functions such as marketing, busi- recapture slot in India’s top pharma-
ness development, HR, new product ceutical companies,” the company
Pfi zer launches commercial analytics centre in Mumbai This office will be the central development, admin, and medical said in a stock market filing.

American pharma major, Pfi zer Inc., and is positioned to be a global The centre is expected to accelerate Fermenta Biotech gets EU GMP certifi cation
has launched the company’s fi rst capability centre for all of Pfizer’s data science and AI solutions to meet
ever dedicated commercial analytics international (outside of the US) Pfi zer’s ambitions in modernising for Dahej facility
centre in India called, the ‘Analytics markets to bring analytics, and in- marketing and creating an agile sales
Gateway’. sight breakthroughs that will benefi t force. It will also drive continuous Fermenta Biotech Ltd. has in- certifi cate of GMP compliance from The company said the approval
patients, a note from the company commercial effectiveness, enabling formed the stock exchanges that the the Competent Authority of Germany, indicates its commitment to ensuring
The centre located in Mumbai said. The centre comprises an expe- Pfi zer to bring more of its medicines company’s Active Pharmaceutical after a European Union Good Manu- that quality assurance is in conformance
represents a milestone in Pfizer’s rienced pool of data and analytics to more patients in India and around Ingredient (API) manufacturing faci- facturing Practice (EU GMP) inspec- with the demanding standards of Good
international commercial strategy experts, it added. the world. lity in Dahej, Gujarat, was awarded a tion in March 2024. Manufacturing Practices.

146 Chemical Weekly October 1, 2024 Chemical Weekly October 1, 2024 147

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