Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 3
Drug Approval
Drug Approval | 14 May 2025

Briefs: Zydus and CuraTeQ Biologics

CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA

Drug Approval
Drug Approval | 14 May 2025

Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy

Drug Approval
Drug Approval | 13 May 2025

Wanbury's Tanuku facility granted GMP certificate by ANVISA

The inspection conducted from December 16, 2024 to December 20, 2024 by the Brazil Health Regulatory Agency (ANVISA)

Drug Approval
Drug Approval | 12 May 2025

Zydus receives final approval from USFDA for Glatiramer Acetate Injection

Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes

Drug Approval
Drug Approval | 08 May 2025

Lupin launches Eslicarbazepine Acetate tablets in US

Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity

Drug Approval
Drug Approval | 06 May 2025

Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site

he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice

Drug Approval
Drug Approval | 06 May 2025

Innoxel Lifesciences completes USFDA inspection

This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence

Drug Approval
Drug Approval | 03 May 2025

Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,

Drug Approval
Drug Approval | 03 May 2025

USFDA inspection at Concord Biotech’s API facility at Dholka

These observations are procedural in nature and none of them are related to data integrity

Drug Approval
Drug Approval | 03 May 2025

Neuland Laboratories completes USFDA inspection at Unit 2

The FDA issued Form 483 with one observation related to building and facility management

Drug Approval
Drug Approval | 02 May 2025

Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP

Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)

Drug Approval
Drug Approval | 01 May 2025

USFDA inspects Marksans’s subsidiary Time-Cap Laboratories' manufacturing facility

The Subsidiary has received one inspectional observation in Form 483

Drug Approval
Drug Approval | 01 May 2025

Strides receives USFDA approval for anti-inflammatory Celecoxib Capsules

Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base

Drug Approval
Drug Approval | 01 May 2025

Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution

This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Drug Approval
Drug Approval | 29 April 2025

IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen

This approval authorizes the company to export Ibuprofen to the Chinese markets

Drug Approval
Drug Approval | 29 April 2025

Closure of USFDA inspection at Zydus' API Unit at Dabhasa, Gujarat

The inspection concluded with 6 observations and none of them were related to Data Integrity

Drug Approval
Drug Approval | 28 April 2025

Biocon Biologics receives positive CHMP opinions for biosimilar Denosumab in Europe

The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited

Drug Approval
Drug Approval | 28 April 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein

Drug Approval
Drug Approval | 24 April 2025

Lupin receives USFDA approval for Tolvaptan Tablets

Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease

Drug Approval
Drug Approval | 24 April 2025

Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion

Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K

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