IPP Bureau

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

By IPP Bureau - May 03, 2025

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

USFDA inspection at Concord Biotech’s API facility at Dholka
USFDA inspection at Concord Biotech’s API facility at Dholka

By IPP Bureau - May 03, 2025

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

Vanta Bioscience receives GLP compliance re-certification
Vanta Bioscience receives GLP compliance re-certification

By IPP Bureau - May 03, 2025

This recertification of Company's OECD GLP is testimony to company's unwavering commitment to maintain international quality standards at the facility

Neuland Laboratories completes USFDA inspection at Unit 2
Neuland Laboratories completes USFDA inspection at Unit 2

By IPP Bureau - May 03, 2025

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

Sanofi Consumer Healthcare India Q1 PAT up 12.9%
Sanofi Consumer Healthcare India Q1 PAT up 12.9%

By IPP Bureau - May 03, 2025

The Q1 2025 also witnessed a successful launch of Allegra D

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

By IPP Bureau - May 02, 2025

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

Vimta Labs posts Q4 FY25 PAT at Rs. 18.31 Cr
Vimta Labs posts Q4 FY25 PAT at Rs. 18.31 Cr

By IPP Bureau - May 01, 2025

Vimta Labs has reported total income of Rs. 96.08 crores during the period ended March 31, 2025

Sigachi Industries signs MoU with Respilon Group
Sigachi Industries signs MoU with Respilon Group

By IPP Bureau - May 01, 2025

This partnership marks a significant milestone in Sigachi's strategy to expand into advanced drug delivery technologies.

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

By IPP Bureau - May 01, 2025

The Subsidiary has received one inspectional observation in Form 483

Strides receives USFDA approval for anti-inflammatory Celecoxib Capsules
Strides receives USFDA approval for anti-inflammatory Celecoxib Capsules

By IPP Bureau - May 01, 2025

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

CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings

By IPP Bureau - May 01, 2025

Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings

Briefs: Alembic Pharmaceuticals  and Bafna Pharmaceuticals
Briefs: Alembic Pharmaceuticals and Bafna Pharmaceuticals

By IPP Bureau - May 01, 2025

Alembic Pharmaceuticals commissions new facility at Pithampur

Dr. Morepen launches Rs. 499 annual multivitamin pack on Labour’s Day
Dr. Morepen launches Rs. 499 annual multivitamin pack on Labour’s Day

By IPP Bureau - May 01, 2025

Priced at just Rs. 499 for 1-year supply, this initiative is aligned with the vision of Health for All

Aster DM Healthcare completes acquisition of 5% stake in Quality Care India
Aster DM Healthcare completes acquisition of 5% stake in Quality Care India

By IPP Bureau - May 01, 2025

The transaction structured as share swap, is valued at ~Rs. 849 crore, with no cash outflow

Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution
Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution

By IPP Bureau - May 01, 2025

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

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