Drug firm Lupin on Thursday said it has received USD 25 million (around Rs 205 crore) from AbbVie Inc for meeting a key development milestone for a product to treat hematological cancers. The company has achieved a key milestone for its novel MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program that is partnered with AbbVie Inc towards treatment across a range of hematological cancers, the Mumbai-based drug maker said in a statement. As part of the agreement, Lupin has received USD 25 million from AbbVie for initiation of Phase 1 clinical studies successfully, it added. The drug maker had earlier received USD 30 million from AbbVie for achievement of other milestones in the programme. "This achievement is further validation of our ability to successfully develop novel treatments for unmet needs. We look forward to continued successful development of this important treatment for patients with difficult-to-treat cancers," Lupin Managing Directo
As such the API business contributes around 7 percent to Lupin's overall turnover
Stocks to Watch on June 27, 2023: Lupin: As per reports, Lupin is considering a restructuring move to unlock value by demerging its API (active pharmaceutical ingredients) business
Lupin's shares declined 4.5 per cent in Thursday's intra-day trade
Lupin has received US FDA nod for Tiotropium Bromide Inhalation Powder in the strength of 18 mcg per capsule. The drug is a generic equivalent of Spiriva HandiHaler, used for pulmonary patients
Collaboration to enhance healthcare services, ensure timely diagnosis, and improve accessibility of healthcare services
Lupin Limited received an inspection classification of "No Action Indicated" (NAI) after the inspection, which was conducted between March 6 to March 10
Diazepam Rectal Gel had estimated annual sales of $34 million in the US
Analysts believe the stock is factoring margin recovery and certain niche launches in the US.
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The revenue growth came from a strong API business performance along with US and domestic market sales growth
The company has entered into a definitive agreement to acquire the entire share capital of Medisol, subject to approval from the French Ministry of Economy and Finance
After establishing a presence in Hyderabad, this launch expands footprint in South India
In a digital health venture, I would love to go into areas where we have equity with doctors. Respiratory is one area where I am very interested in, says Nilesh Gupta, MD, Lupin
Drug firm Lupin on Thursday said the US health regulator has issued a Form-483 with ten observations after inspecting its Pithampur Unit-2 manufacturing facility. The US Food and Drug Administration (USFDA) inspected the plant from March 21 to March 29, 2023. The inspection closed with issuance of a Form-483 with ten observations, Lupin said in a regulatory filing. "We are addressing the observations comprehensively and will work with the US FDA to resolve these issues at the earliest," it added. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. In October 2022, the drugmaker announced that the US health .
Pharmaceuticals firm Lupin Ltd on Monday said it has received tentative approval from the US health regulator to market its generic valbenazine capsules used to treat involuntary movements of the face, tongue or other body parts. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of valbenazine capsules of strengths 40 mg, 60 mg and 80 mg, the company said in a regulatory filing. These are the generic equivalent of Ingrezza capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc, it added. Valbenazine capsules had estimated annual sales of USD 1,235 million in the US, the company said, citing IQVIA MAT December 2022 data.
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Pharmaceuticals firm Lupin Ltd on Tuesday said it has received approval from the US health regulator for its generic Brexpiprazole tablets used to treat the symptoms of schizophrenia and depression. The approval granted by the US Food and Drug Administration (US FDA) is for the abbreviated new drug application for Brexpiprazole tablets of strengths 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, the company said in a regulatory filing. These are generic equivalent of Rexulti tablets of Otsuka Pharmaceutical Company Ltd, it added. "This product would be manufactured at Lupin's Pithampur facility in India," the company said. Lupin said Brexpiprazole tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, had an estimated annual sales of USD 1,575 million in the US, citing IQVIA MAT December 2022 data.