Tag: FDAApproval

  • Caplin Point Laboratories’ Subsidiary Caplin Steriles Gains USFDA Approval for Seizures Treatment Injection

    Caplin Steriles, a subsidiary of Caplin Point Laboratories, has received USFDA approval for its Levetiracetam in sodium chloride injection, a significant addition to its portfolio. This generic antiepileptic drug targets the growing demand for seizure treatments and positions Caplin Steriles for further expansion in the global pharmaceutical market.

  • Lupin Ltd. Expands Investment Portfolio with Acquisition of 42.61% Stake in Sunsure Solarpark

    Lupin Ltd. has acquired a 42.61% stake in Sunsure Solarpark for Rs 10.5 crore, marking its entry into the renewable energy sector. This strategic move follows the company’s recent FDA approval for its cystic fibrosis treatment, Ivacaftor oral granules, as Lupin diversifies its business portfolio for long-term growth.

  • Alembic Pharma Receives USFDA Approval for Seizure Treatment Drug

    Alembic Pharmaceuticals has secured USFDA approval for its Divalproex Sodium Delayed-Release Capsules, offering an affordable alternative to the brand-name drug Depakote. This approval expands Alembic's portfolio in the anti-epileptic market, with significant growth potential. Discover more about the impact of this approval and the company's financial performance.

  • Granules India Secures USFDA Approval for ADHD Drug, Strengthening Global Presence

    Granules India has achieved a significant milestone with USFDA approval for its generic Lisdexamfetamine Dimesylate chewable tablets, providing a more affordable option for treating ADHD and binge eating disorder. This approval addresses critical drug shortages in the U.S. and strengthens Granules’ presence in the global pharmaceutical market.

  • Lupin’s Pune Biotech Facility Receives FDA Observations: Implications and Analysis

    Lupin Pharmaceuticals faces a significant moment as its Pune biotech facility receives five observations from the FDA during a recent pre-approval inspection. While this poses regulatory challenges, the company continues to showcase robust financial growth, with a 76% increase in net profit. In this post, we delve into the implications of the FDA's findings, Lupin's strategies for addressing these issues, and what it means for investors and the future of its biotech products

  • Alembic Pharmaceuticals Secures FDA Approval for Alcaftadine Ophthalmic Solution

    Alembic Pharmaceuticals has achieved a major milestone with the FDA approval of its Alcaftadine Ophthalmic Solution, designed to relieve itchy eyes caused by common allergens. This new product positions Alembic to strengthen its presence in the ophthalmic market, alongside a solid financial performance that highlights the company's growth potential. Explore the implications of this approval and what it means for allergy sufferers and the pharmaceutical industry.

  • Strides Pharma Secures USFDA Approval for Theophylline Extended-Release Tablets

    Strides Pharma Science Ltd has secured USFDA approval for its generic version of Theophylline Extended-Release Tablets, marking a significant milestone for the company. Available in 300 mg and 450 mg strengths, this new generic option offers a cost-effective solution for managing chronic respiratory conditions such as asthma. With this approval, Strides Pharma aims to expand its market presence and provide patients with affordable, high-quality medication alternatives.

  • Sun Pharma’s LEQSELVI Receives USFDA Approval for Alopecia Areata

    Sun Pharma's LEQSELVI (deuruxolitinib) has recently received USFDA approval for the treatment of severe alopecia areata. This new JAK inhibitor represents a significant advancement in managing this autoimmune disorder, offering patients a promising option for combating unpredictable hair loss. In this blog, we delve into the details of LEQSELVI’s clinical results, how it works, and what it means for those affected by severe alopecia areata.

  • Zydus Lifesciences Receives Tentative Approval from USFDA for BP Lowering Drug

    In a significant development, Zydus Lifesciences has achieved tentative approval from the FDA for its Azilsartan Medoxomil tablets, marking a pivotal step in expanding treatment options for hypertension. Learn more about how this milestone underscores Zydus Lifesciences' dedication to delivering quality healthcare solutions.