Lupin announced that its subsidiary Novel Laboratories has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System. This product is a generic equivalent of Diastat AcuDial Rectal Delivery System, 10 mg and 20 mg, which is […]
Lupin, an Indian pharmaceutical company, has announced a strategic collaboration with Enzene Biosciences, a subsidiary of Alkem Laboratories, to introduce Cetuximab in India. Cetuximab is the first biosimilar developed for Eli Lilly and Company’s Cetuximab, a monoclonal antibody medication used in the treatment of various types of cancer, including head and neck cancer and metastatic […]
Lupin has announced that its subsidiary in Canada, Lupin Pharma Canada has received approval from Health Canada to market a generic version of Spiriva (tiotropium bromide inhalation powder) for the treatment of chronic obstructive pulmonary disease (COPD) in Canada. Tiotropium Bromide Inhalation Powder is used as a long-term maintenance bronchodilator for patients with COPD, including […]
Indian healthcare company Lupin has announced the establishment of a satellite laboratory in Vijayawada, Andhra Pradesh, as part of its ongoing expansion in the diagnostics sector. The move aims to improve access to high-quality testing services and extend the reach of Lupin Diagnostics’ network across the country. This addition complements Lupin Diagnostics’ existing 27 laboratories […]
Indian pharma company Lupin has agreed to acquire Medisol, a French pharmaceutical company, for an undisclosed price. Established in 2011, Medisol is engaged in developing generics injectable products and commercializing them in pharmacies and hospitals in France. The acquisition will help Lupin get access to a portfolio of seven injectable products of Medisol, which are […]
Lupin Diagnostics, a subsidiary of Indian pharma company Lupin, has opened its new regional reference laboratory in Bengaluru as part of the growth of its diagnostics network. The new lab is said to be a major step forward in Lupin Diagnostics’ mission to provide affordable and accessible health services and diagnostics throughout India. Lupin said […]
Lupin said that it has been issued tentative approval for Obeticholic Acid Tablets, 5 mg and 10 mg from the US Food and Drug Administration (FDA). The Indian pharma company approval is for the abbreviated new drug application (ANDA) for marketing a generic version of Intercept Pharmaceuticals’ Ocaliva Tablets, 5 mg and 10 mg. As […]
Lupin Limited said that its alliance partner Caplin Steriles has won final approval for Rocuronium Bromide Injection, 10mg/mL in 5 mL and 10 mL multi-dose vials from the US Food and Drug Administration (FDA). The approved abbreviated new drug application (ANDA) of the Indian pharma company is for marketing a generic version of Organon USA’s […]
Lupin said that the US Food and Drug Administration (FDA) has concluded an inspection of the company’s bioresearch centre in Pune, Maharashtra. The inspection was completed without any observation, said the Indian pharma company. Lupin’s bioresearch centre carries out bioavailability/bioequivalence (BA/BE), pharmacokinetics/pharmacodynamics (PK/PD), in-vitro BE, and biosimilar studies. Nilesh Gupta — Lupin Managing Director said: […]
Lupin said that the US Food and Drug Administration (FDA) has wrapped up a pre-approval and GMP inspection of its API manufacturing plant in Visakhapatnam, Andhra Pradesh. The FDA inspection was undertaken from 6 March to 10 March 2023 and was completed without any observations. Nilesh Gupta — Lupin Managing Director said: “We are pleased […]