IPP Bureau

Borosil Scientific to shift unit at Ambad to Bharuch
Borosil Scientific to shift unit at Ambad to Bharuch

By IPP Bureau - February 27, 2025

This will lead to the consolidation and optimization of the company's operations related to the manufacturing of ampoules and vials

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit
USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

By IPP Bureau - February 27, 2025

The observations issued are neither repeated observations nor related to data integrity

Briefs: Emcure and Relonchem
Briefs: Emcure and Relonchem

By IPP Bureau - February 27, 2025

USFDA inspection at Emcure Pharmaceuticals API facility

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

By IPP Bureau - February 27, 2025

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure

Senores Pharmaceuticals begins operations at greenfield API facility
Senores Pharmaceuticals begins operations at greenfield API facility

By IPP Bureau - February 27, 2025

This is Senores' second API manufacturing facility adding significantly to the existing API manufacturing capabilities.

Venus Remedies secures in-licensing rights from Infex Therapeutics to develop and commercialize MET-X in India
Venus Remedies secures in-licensing rights from Infex Therapeutics to develop and commercialize MET-X in India

By IPP Bureau - February 27, 2025

MET-X, a novel metallo-beta-lactamase (MBL) inhibitor, has shown best-in-class performance in preclinical studies

Glenmark Pharmaceuticals USA launches Epinephrine Injection USP
Glenmark Pharmaceuticals USA launches Epinephrine Injection USP

By IPP Bureau - February 27, 2025

This launch of Epinephrine Injection multiple-dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.

India’s CRDMO sector growth potential at $22 - $25 Billion by 2035: BCG-IPSO Report
India’s CRDMO sector growth potential at $22 - $25 Billion by 2035: BCG-IPSO Report

By IPP Bureau - February 26, 2025

Eleven CRDMOs collaborate to form IPSO with the aim to elevate India’s position in the global pharmaceutical value-chain

Merck unveils formulation and technology center in Navi Mumbai
Merck unveils formulation and technology center in Navi Mumbai

By IPP Bureau - February 26, 2025

The Formulation & Technology Centre intends to function as a technology storefront, offering advanced formulation and processing solutions to address the growing demand for complex drug formulations

Cadila Pharmaceuticals opens advanced pharmaceutical warehouse
Cadila Pharmaceuticals opens advanced pharmaceutical warehouse

By IPP Bureau - February 26, 2025

FDA grants EUA to Aptitude’s Covid/flu multiplex test for OTC use
FDA grants EUA to Aptitude’s Covid/flu multiplex test for OTC use

By IPP Bureau - February 26, 2025

Amgen opens new technology and innovation site in Hyderabad
Amgen opens new technology and innovation site in Hyderabad

By IPP Bureau - February 25, 2025

Amgen India investment totals $200 million through 2025

Biocon Biologics launches Yesintek Biosimilar to Stelara in US
Biocon Biologics launches Yesintek Biosimilar to Stelara in US

By IPP Bureau - February 25, 2025

YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis

Indegene launches AI platform Cortex
Indegene launches AI platform Cortex

By IPP Bureau - February 25, 2025

This innovative platform is strategically essential to developing and scaling high-value life sciences use cases such as streamlining the content supply chain

Teva and Sanofi present new outcome from Phase 2b study of duvakitug
Teva and Sanofi present new outcome from Phase 2b study of duvakitug

By IPP Bureau - February 25, 2025

Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025

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