Tag: GenericDrugs
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Glenmark Pharmaceuticals Launches Epinephrine Injection in the US, Secures CGT Exclusivity
Glenmark Pharmaceuticals has launched a generic version of Epinephrine Injection in the US, providing a more affordable option for treating severe allergic reactions like anaphylaxis. This FDA-approved medication is bioequivalent to the branded version and comes with a 180-day Competitive Generic Therapy exclusivity, offering both cost savings and improved access to life-saving treatment.
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Dr. Reddy’s Laboratories Receives EIR from USFDA for Hyderabad API Facility
Dr. Reddy's Laboratories has received the USFDA's Establishment Inspection Report (EIR) for its Hyderabad API facility, signaling regulatory compliance. This comes alongside a strong Q3 FY25 performance, with a rise in net profit and sales, reinforcing the company's position in the global pharmaceutical market.
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Glenmark Pharmaceuticals Launches Generic Clindamycin Phosphate Foam in the US Market
Glenmark Pharmaceuticals has introduced its generic version of Clindamycin Phosphate Foam 1% in the US, providing a cost-effective solution for acne treatment. This launch offers the same therapeutic benefits as the brand-name product, Evoclin, at a more affordable price, making acne care more accessible to patients.
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Natco Pharma Secures USFDA Approval for Bosentan Tablets for Oral Suspension (32mg): A Game-Changer in PAH Treatment
Natco Pharma has received USFDA approval for its generic Bosentan tablets for oral suspension (32mg), a key treatment for pediatric pulmonary arterial hypertension (PAH). With First-to-File status, Natco is poised to capture significant market share through a 180-day exclusivity period. This approval opens new opportunities for Natco and its partner Lupin Pharmaceuticals in the growing U.S. pediatric PAH market, addressing a critical need for easier-to-administer treatments.
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Natco Pharma Secures Approval for Generic Everolimus Tablets for Oral Suspension in the U.S.
Natco Pharma has received FDA approval for its generic version of Everolimus tablets for oral suspension (TFOS), providing a more affordable treatment option for patients with TSC-related SEGA. This approval marks a significant milestone in the generics market, offering greater access to a critical therapy for both adult and pediatric patients.
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Lupin Gains USFDA Approval for Generic HIV Medication
Lupin has received tentative approval from the USFDA for its generic version of the HIV drug Triumeq PD, combining Abacavir, Dolutegravir, and Lamivudine. This approval paves the way for more affordable HIV treatment options, particularly in underserved regions, enhancing access to life-saving care.