Pharmaceutical giant, Lupin Limited, has achieved a significant milestone by obtaining the US Food and Drug Administration (FDA)’s green light for its Abbreviated New Drug Application (ANDA) of Doxycycline Hyclate Delayed-Release Tablets USP in multiple doses. This nod from the FDA paves the way for Lupin to introduce a generic counterpart of the popular Doryx […]
Lupin Limited said that their wholly-owned US subsidiary, Novel Laboratories Inc., has secured approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Fluocinolone Acetonide Oil, 0.01% (Body Oil). This product stands as the generic counterpart to DermaSmoothe/FS 0.01% (Body Oil) originally by Hill Dermaceuticals, Inc. Commercial […]
Indian cardiac digital therapeutics entity, Lupin Digital Health (LDH), marked another achievement with the unveiling of its Lyfe Digital Heart Failure Clinic. Designed to cater to the escalating 10 million-plus heart failure patients in India, this avant-garde e-clinic blends the convenience of home-based care with the precision of in-clinic consultations. Addressing India’s Cardiac Health Concerns […]
Lupin Limited, a leading global pharmaceutical company, has received tentative approval for its New Drug Application (NDA) for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets from the US Food and Drug Administration (US FDA). The approval, granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), gives Lupin the green light to manufacture the product […]
Lupin Inc., a wholly-owned subsidiary of the global pharmaceutical major Lupin Limited, announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP in various strengths. The approval permits the New Jersey-based company to market a generic equivalent to […]
Global pharmaceutical corporation, Lupin Limited has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Pithampur Unit-2 facility in Madhya Pradesh. This manufacturing unit, which produces oral solids and ophthalmic dosage forms, underwent its last inspection from March 21 to March 29, 2023. The US FDA classified the […]
Indian pharmaceutical company Lupin announced that the US Food and Drug Administration (FDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) for Dolutegravir Tablets for Oral Suspension, 5 mg. This approval will allow Lupin to market a generic equivalent of ViiV Healthcare’s Tivicay PD Tablets for Oral Suspension, 5 mg. The tablets […]
Indian pharma titan Lupin has announced receiving approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule. This medication is a generic equivalent of Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), an 18 mcg/capsule product of Boehringer Ingelheim Pharmaceuticals, Inc. Lupin will manufacture this […]
Indian pharmaceutical company Lupin has announced its approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Obeticholic Acid Tablets, 5 mg and 10 mg. In March 2023, Lupin was issued tentative approval for Obeticholic Acid Tablets, 5 mg and 10 mg from the FDA. These tablets are […]
Lupin, an Indian pharmaceutical company, has announced the launch of Darunavir Tablets, available in 600mg and 800mg variants in the US. These tablets serve as a generic equivalent to Janssen Products’ Prezista Tablets (darunavir). Darunavir, the active ingredient in both the 600mg and 800mg tablets, is a highly potent protease inhibitor used in the treatment […]