Earlier on 26 October 2022, the US drug regulator placed the Baddi, India facility under import alert 66-40 following the inspection conducted in June 2022.

Atovaquone is used to prevent or treat a serious lung infection called pneumocystis pneumonia (PCP). The drug maker said that the exception will be reconsidered if the market conditions change.

The company said that it will engage with the agency to resolve the import alert at the earliest. It is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe.

Glenmark Pharmaceuticals is primarily engaged in the business of development, manufacture and marketing of pharmaceutical products.

On consolidated basis, the company's net profit rose 1.1% to Rs 260.44 crore on 6% jump in net sales to Rs 3,312.49 crore in Q2 FY23 over Q2 FY22.

The scrip slipped 4.36% to currently trade at Rs 381.60 on the BSE.

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Glenmark Pharmaceuticals announced that due to medical necessity and potential drug shortage expectations, the US FDA has provided an exception to the import alert 66-40 place on its Baddi facility which enables the Company to supply Atovaquone Oral Suspension USP 750mg/5 to the US market. The exception will be reconsidered if the market conditions change.

The Company will engage with the agency to resolve the import alert at the earliest. The Company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe.

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AKYNZEO I.V is used for the prevention of chemotherapy-induced nausea and vomiting (CINV). It is a fixed dose combination of fosnetupitant (235 mg) and palonosetron (0.25 mg) and is available as a ready-to-dilute I.V. injection.

It is administered as a single infusion 30 minutes prior to the start of each chemotherapy cycle that helps prevent, both, acute and delayed phases of CINV. The drug is already being marketed in the EU, the US, and Australia.

As per the latest National Cancer Registry Programme data, cancer cases in the country are projected to rise by 12.8% by 2025 from 13.9 lakh cases in 2020.

Glenmark has a strong legacy of being the first to introduce new and effective prophylactic treatment options for CINV among the cancer patients in India. Around two decades ago, it had launched Aprecap (Aprepitant capsules), the first NK1 receptor blocker, and few years later, introduced Aprecap I.V. injection. Subsequently in 2018, Glenmark launches AKYNZEO oral capsules, the first and only CINV prevention therapy to prevent both acute and delayed phases of CINV by a single dose.

Alok Malik, EVP & business head ‐ India Formulations, Glenmark Pharmaceuticals, said, Chemotherapy is the most common form of cancer treatment, with nausea and vomiting being two of its most debilitating side‐effects. AKYNZEO I.V. is a convenient, single‐dose, ready‐to‐dilute I.V. injection that covers, both, the acute and the delayed phases of CINV, thereby enabling patients to avoid multiple antiemetic drugs, and improving compliance.

Helsinn Group CEO, Giorgio Calderari, said, We are delighted to partner with Glenmark who has an excellent footprint in this region and is trusted with providing the best treatment options for cancer patients.

Glenmark Pharmaceuticals is primarily engaged in the business of development, manufacture and marketing of pharmaceutical products.

On consolidated basis, the company's net profit rose 1.1% to Rs 260.44 crore on 6% jump in net sales to Rs 3,312.49 crore in Q2 FY23 over Q2 FY22.

The scrip rose 0.35% to Rs 419.40 on the BSE.

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Glenmark Pharmaceuticals is the first to launch in India a unique I.V. injection formulation, AKYNZEO® I.V., for the prevention of chemotherapy-induced nausea and vomiting (CINV), under an exclusive licensing agreement with Helsinn, a Swiss biopharma group company.

AKYNZEO® I.V. is a fixed dose combination of fosnetupitant (235 mg) and palonosetron (0.25 mg), and is available as a ready-to-dilute I.V. injection. It is administered as a single infusion 30 minutes prior to the start of each chemotherapy cycle that helps prevent, both, acute and delayed phases of CINV. The drug is already being marketed in the EU, the US, and Australia.

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