相关临床试验
21
15 进行中
药物批准
323
批准总数
监管机构
4
监管机构数
成立时间
N/A
进行中（未招募）
4
19.1%
已完成
4
19.1%
尚未招募
11
52.4%
招募中
2
9.5%
- Natco Pharma received tentative USFDA approval for generic Olaparib tablets (100 mg and 150 mg), deemed bioequivalent to AstraZeneca's Lynparza®. - Alembic Pharmaceuticals will distribute the product in the U.S. market while Natco handles manufacturing, with ongoing Para IV litigation. - Olaparib tablets generated estimated U.S. sales of approximately USD 1.4 billion over the 12 months ending March 2026, per IQVIA data. - This marks Alembic's 244th ANDA approval from the USFDA, comprising 224 final and 20 tentative approvals.
- Alembic Pharmaceuticals Limited received an Establishment Inspection Report (EIR) from the USFDA for its API-I and API-II facilities at Panelav following a May 26-31, 2025 inspection. - The facilities initially received four observations during the inspection but have now been cleared with the issuance of the EIR. - Separately, Tyche Industries Limited successfully completed a GMP inspection by Brazil's ANVISA regulatory agency at its Kakinada facility in September 2025.
- DelveInsight's 2025 pipeline analysis reveals over 75 companies actively developing more than 90 therapeutic candidates for epilepsy treatment, indicating a dynamic and expanding research landscape. - Recent regulatory milestones include Alembic's FDA approval for generic Depakote Sprinkle and Aquestive Therapeutics receiving seven years of orphan drug exclusivity for Libervant buccal film for pediatric seizure clusters. - Leading pipeline candidates include EPX-100 from Harmony Biosciences in Phase III development, along with promising therapies like BMB-101, STK-001, NRTX-1001, and IAMA-6 in various clinical stages. - The pipeline encompasses diverse therapeutic approaches including monoclonal antibodies, small molecules, and peptides, delivered through multiple administration routes from oral to intravenous formulations.
- Alembic Pharmaceuticals has received USFDA final approval for its Diltiazem Hydrochloride Extended-Release Capsules USP, in multiple strengths. - The approved ANDA is therapeutically equivalent to Cardizem CD, used for treating hypertension, chronic stable angina, and angina due to coronary artery spasm. - Diltiazem Hydrochloride Extended-Release Capsules had an estimated market size of US$105.3 million for the twelve months ending June 2024. - Alembic now has a cumulative total of 218 ANDA approvals from the USFDA, including 191 final and 27 tentative approvals.
