Page 145 - CW E-Magazine (12-12-2023)

Pharmaceuticals

OVEREAS APPROVAL
Aurobindo Pharma gets USFDA nod to make,

market asthma drug

Aurobindo Pharma has said its
wholly-owned subsidiary, Eugia Pharma
Specialities Ltd. (EPSL), had
received the fi nal nod from the USFDA
to manufacture and market an asthma
drug.
EPSL will make and sell Budeso-
nide Inhalation Suspension, 0.5 mg/2-
mL Single-Dose Ampoule. The drug
is bioequivalent and therapeutically
equivalent to the reference listed drug
(RLD), Pulmicort Respules (bude-
sonide) inhalation suspension by Astra-
Zeneca Pharmaceuticals.

The drug is expected to be launched Nod for HIV drug the Hyderabad-based drug maker said
in FY25, and had an estimated market The approval comes a day after the in a regulatory fi ling.
size of $226.4-mn for the 12 months company said it received a separate
ending September 2023, according to approval from the US health regulator Darunavir, in combination with
IQVIA, an analytical research agency. to market a generic medication for the other antiretroviral agents, is indicated
treatment of human immunodefi ciency for the treatment of HIV-1 infection in
This is the 173rd ANDA approval virus (HIV-1) infection. adult and paediatric patients three years
(including nine tentative approvals of age and older. As per IQVIA, the
received) out of EPSL’s facilities, manu- The company received fi nal appro- approved product has an estimated mar-
facturing both oral and sterile specialty val to manufacture and market Darunavir ket size of $274.8-mn for the 12 months
products. tablets in strengths of 600-mg and 800 mg, ended October 2023.

MANUFACTURING INFRASTRUCTURE
Cadila Pharma inaugurates API plant at Dahej

Cadila Pharmaceuticals Ltd. CPL) “This state-of-the-art API manufac-
has inaugurated its state-of-the-art turing facility at Dahej represents our
Active Pharmaceutical Ingredients (APIs) commitment to providing high-quality,
plant at Dahej in Bharuch district of cost-effective APIs to our customers
Gujarat. worldwide. The DCS technology used
in this facility will allow us to pro-
The facility, set up with an invest- duce APIs with a high level of purity
ment of Rs. 200-crore, is equipped with and consistency, while also reducing
the latest Distributed Control System the environmental impact. This facility
(DCS) automation technology, marking Dr. H.G. Koshia, Food Drug Com- is designed to be highly effi cient,
a signifi cant milestone in Cadila Pharma- missioner for Gujarat, and Dr. M.P. aiding us in meeting the growing
ceuticals’ dedication to innovation and Nakarani, Assistant Commissioner, demand for our products,” Mr. Biswajit
excellence in drug manufacturing, the FDCA, Bharuch Circle, were present at Mitra, Chief Mentoring Offi cer, CPL,
company said in a statement. the inaugration. said in a statement.

Chemical Weekly December 12, 2023 145

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