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Results For "ANDA"

2464 News Found

Akums’ Haridwar factory receives ANVISA GMP certification for sterile manufacturing plant
Drug Approval | July 28, 2025

Akums’ Haridwar factory receives ANVISA GMP certification for sterile manufacturing plant

This certification validates the plant’s robust capabilities in manufacturing a wide range of sterile dosage forms


Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP
Drug Approval | July 27, 2025

Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug


Concord Biotech successfully completes Russian GMP inspection at its API facility
Drug Approval | July 27, 2025

Concord Biotech successfully completes Russian GMP inspection at its API facility

The inspection was conducted from July 22-25, 2025


RPG Life Sciences Q1 FY2026 PAT slips to Rs. 26.29 Cr
News | July 26, 2025

RPG Life Sciences Q1 FY2026 PAT slips to Rs. 26.29 Cr

RPG Life Sciences has reported total income of Rs. 174.15 crores during the period ended June 30, 2025


Indoco receives EU GMP certificate for its sterile manufacturing facility in Goa
News | July 26, 2025

Indoco receives EU GMP certificate for its sterile manufacturing facility in Goa

This GMP certification for our sterile drug product manufacturing facility, Goa Plant II is a testament to our relentless efforts to supply quality and affordable medicines across geographies


Zydus receives tentative approval from USFDA for Ibrutinib tablets
Drug Approval | July 24, 2025

Zydus receives tentative approval from USFDA for Ibrutinib tablets

Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad


Miltenyi Biotec and THSTI partner to launch CAR-T Cell and gene therapy training curriculum
News | July 21, 2025

Miltenyi Biotec and THSTI partner to launch CAR-T Cell and gene therapy training curriculum

This collaboration aims to bridge India’s talent and translational gap in this rapidly growing field by equipping professionals with practical expertise in the manufacturing of advanced therapies.


Roche provides update on astegolimab in chronic obstructive pulmonary disease
Clinical Trials | July 21, 2025

Roche provides update on astegolimab in chronic obstructive pulmonary disease

The phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks


AstraZeneca’s Tagrisso plus chemotherapy improves overall survival in EGFR-mutated advanced lung cancer
Clinical Trials | July 21, 2025

AstraZeneca’s Tagrisso plus chemotherapy improves overall survival in EGFR-mutated advanced lung cancer

Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination


Bristol Myers Squibb announces topline Results from Phase 3 Independence trial for Reblozyl
Clinical Trials | July 19, 2025

Bristol Myers Squibb announces topline Results from Phase 3 Independence trial for Reblozyl

Reblozyl is a standard of care for the first-line treatment of anemia without previous erythropoiesis stimulating agent use