Page 148 - CW E-Magazine (19-3-2024)

Pharmaceuticals Pharmaceuticals

RAISING MANUFACTURING STANDARDS AMALGAMATION
Centre expands technology upgradation support Suven Pharma and Cohance Lifesciences announce merger

for pharma industry Suven Pharmaceuticals and Co- over the next 12-15 months, subject to establish Suven’s position as a diver-

hance Lifesciences have announced a receipt of all relevant shareholder and sifi ed CDMO and API leader in the
The Department of Pharmaceuti- dule-M of the Drugs and Cosmetics The DoP also outlined a dynamic proposed scheme of amalgamation for regulatory approvals, the companies country. It would provide three distinct
cals (DoP) has announced a revamped Rule, 1945, issued by the Department incentive structure for pharmaceutical the merger of the two companies. added. growth engines of growth – pharma
Pharmaceuticals Technology Upgrada- of Health and Family Welfare last units, subject to a ceiling of Rs. 1-crore CDMO, speciality chemicals CDMO,
tion Assistance (RPTUAS) Scheme, December. Key features of the scheme per unit: Once the scheme becomes ef- Cohance is a Hyderabad-based and APIs.
expanding the scope of eligibility, include broadened eligibility criteria and  Pharmaceutical units with turnover fective, all shareholders of Cohance CDMO (contract development and
among other things. an “inclusive approach” by expanding of less than Rs. 50-crore will be would be issued shares of Suven in manufacturing organisation) and mer- Last September, Advent had
its scope beyond micro, small, and eligible for incentives corresponding the ratio of 11 shares of Suven for chant API (active pharmaceutical ingre- announced a new board of directors and
“The revised guideline aims to medium enterprises (MSMEs) to include to 20% of investment under eligible every 295 shares of Cohance. The dients) platform with a global presence management team at Suven Pharma,
support the pharmaceutical industry’s “any pharmaceutical manufacturing unit activities; new shares of Suven will be traded in select low-mid volume molecules, having completed the acquisition of the
upgrade to the Revised Schedule-M & with a turnover of less than Rs. 500-crore  Those with turnover from Rs. on the NSE and BSE. Private equity besides capabilities in the form of its Hyderabad-based CDMO. In December
WHO-GMP standards, enhancing the that requires technology and quality 50-crore to less than Rs. 250-crore fi rm, Advent International would own antibody drug conjugates (ADC) plat- 2022, Advent agreed to acquire a 50.1%
quality and safety of pharmaceutical upgradation.” will be eligible for incentives cor- about 66.7% and the public share- form. stake in Suven Pharmaceuticals from
products manufactured in our country,” responding to 15% of investment holders would hold the remaining the Jasti family for Rs. 6,313-crore,
said the DoP, which is under the Ministry However, the note added that there under eligible activities; and 33.3% of the combined entity. The On the rationale behind the move, inking one of the largest pharma deals
of Chemicals and Fertilisers. would be a preference for MSMEs and  Those with turnover from Rs. transaction is expected to conclude the companies said the merger would in recent years.
smaller players in achieving high-qua- 250-crore to less than Rs. 500-crore
The Centre has been tightening regu- lity manufacturing standards. The will be eligible for incentives cor- MANUFACTURING NORMS VIOLATION
latory and manufacturing norms for scheme also introduces more fl exible responding to 15% of investment Sun Pharma recalls 55,000 bottles of generic drug
the pharmaceutical industry ever since fi nancing options, the note said, under eligible activities.
it has come under some intense global “emphasising subsidies on a reimburse- from US market
scrutiny following reports of contami- ment basis over the traditional credit- The revised scheme also allowed
nated cough syrups involving compa- linked approach,” thereby facilitating integration with State Government
nies based in India, among other things. better adoption of the scheme. Further, schemes, enabling units to benefi t from Mumbai-based Sun Pharma is “Microbial contamination was As per the USFDA, the company
the scheme supports a broader range of additional top-up assistance. And it recalling around 55,000 bottles of a reported in stagnant water in the duct has initiated the Class-II nationwide
Key features technological upgrades, the DoP said, introduces a verifi cation mechanism generic medication to treat gout from of the manufacturing equipment,” the (US) recall on March 4 this year. As
The latest approval of the revised outlining eligible activities to include through a project management agency, the American market due to manu- USFDA stated. The affected lot was per the USFDA, a Class-II recall is
scheme comes after a review by the testing laboratories, stability chambers, it said, to ensure transparency, accounta- facturing practices norms deviations, produced at Sun Pharma’s Dadra-based initiated in a situation in which the use
Scheme Steering Committee, against clean room facilities, effl uent treatment, bility, and the effi cient allocation of according to the US health regulator. plant for Memphis-based Northstar Rx of, or exposure to, a violative product
the backdrop of the revised Sche- and waste management, to name a few. resource. The New Jersey-based unit of the drug LLC, the US regulator noted. may cause temporary or medically
major is recalling Febuxostat Tablets in reversible adverse health consequences
40-mg and 80-mg strengths, USFDA Febuxostat is used to lower uric or where the probability of serious
Cadila Pharma launches advanced Quadrivalent said in its latest Enforcement Report. acid levels in people with gout. adverse health consequences is remote.

Infl uenza Vaccine Alembic Pharma gets four observations for Gujarat facility

Alembic Pharmaceuticals has received oral solid) unit at Panelav, Gujarat. This March 8 at the plant. Alembic said that it
Cadila Pharmaceuticals has pany said in a statement. The vaccine well-being of both mother and child, four observations from the USFDA for its follows an inspection carried out by the would provide a comprehensive response
launched the ‘Cadifl u Tetra Vaccine’, aims to reduce the incidence of infl u- the release added. The vaccine targets oncology formulations (injectable and US drug regulator from February 28 to to the FDA within the stipulated period.
an advanced Quadrivalent Infl uenza enza illness, mitigate the severity of four strains of the Infl uenza virus sub-
Vaccine, to prevent infl uenza, a recur- the disease in affected individuals, and type A and B, responsible for seasonal
rent, widespread and debilitating viral decrease the transmission of the infection epidemics. Developed using cutting-edge Sun Pharma gets USFDA all-clear for Ankleshwar unit
infection. to others. This vaccine development proprietary technology employing nano-
also holds promise for enhancing the size particles, the vaccine mimics the The USFDA has given the Active all-clear to manufacture and export highest level of compliance – paving
The vaccine is approved by DCGI protection of pregnant women against external structure of the virus without Pharmaceutical Ingredients (API) unit APIs. The USFDA classifi ed the unit the way for manufacturing and export
for use in adults and children, the com- infl uenza, contributing to the overall containing intact genetic material. of Sun Pharmaceutical Industries the as ‘No Action Indicated (NAI)’ – the from the plant.

148 Chemical Weekly March 19, 2024 Chemical Weekly March 19, 2024 149

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