News about Regulation

Marksans Pharma's UK subsidiary Relonchem Secures MHRA Approval for Clonidine Tablets

Marksans Pharma’s wholly owned UK subsidiary, Relonchem, has received marketing authorisation from the UK Medicines & Healthcare products Regulatory Agency (MHRA) for Clonidine 100 microgram tablets and Clonidine Hydrochloride 25 microgram tablets.

Regulation | 15/10/2025 | By Dineshwori |  393

Celltrion Receives US FDA Approval for EYLEA Biosimilar EYDENZELT

Celltrion has received approval from the US Food and Drug Administration (FDA) for EYDENZELT (aflibercept-boav), a biosimilar to EYLEA (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

Regulation | 11/10/2025 | By Dineshwori |  408

WHO Prequalifies Shanchol Oral Cholera Vaccine

Shanchol remains the only oral cholera vaccine manufactured in India with WHO prequalification, underscoring India’s critical role in ensuring continuity of global supply.

Regulation | 07/10/2025 | By Dineshwori |  588

Biocon and Carnegie Secure Tentative FDA Approval for Rifaximin Tablets

Biocon Pharma, a wholly owned subsidiary of Biocon Ltd., in partnership with Carnegie Pharmaceuticals, has received tentative approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg.

Regulation | 07/10/2025 | By Dineshwori |  535

Zydus Receives USFDA Approval for Deflazacort Oral Suspension

Zydus stated that deflazacort oral suspension will be produced at Doppel, Italy.

Regulation | 06/10/2025 | By Dineshwori |  202

FDA Announces New ANDA Prioritisation Pilot to Support US Generic Drug Manufacturing and Testing

More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for Active Pharmaceutical Ingredients (APIs). As of 2025, only nine percent of API manufacturers are in the US, compared to 22 percent in China and 44 percent in India.

Regulation | 06/10/2025 | By Dineshwori |  201

Sitryx receives FDA clearance of IND application for SYX-5219 for the treatment of atopic dermatitis

Sitryx’s SYX-5219 is a first-in-class, oral, disease-modifying, anti-inflammatory therapy, targeting pyruvate kinase M2 (PKM2), a critical enzyme that regulates cell metabolism.

Regulation | 04/10/2025 | By Dineshwori |  346

CDSCO approves AstraZeneca's Trastuzumab Deruxtecan for More HER2-Positive Tumours

With this, Trastuzumab Deruxtecan becomes India’s first Antibody Drug Conjugate (ADC) approved for a tumour-agnostic indication.

Regulation | 04/10/2025 | By Dineshwori |  344

Rajasthan Bans Distribution of 19 Kaysons Pharma Medicines, Suspends Drug Controller

The Rajasthan government has ordered the suspension of distribution for 19 medicines marketed by Kaysons Pharma, citing serious concerns over drug safety. Concurrently, the state has suspended its Drug Controller, Rajaram Sharma, in connection with alleged irregularities in setting quality standards.

Regulation | 04/10/2025 | By Darshana |  228

CDSCO Clarifies Approval Process for Lyophilized Injection Combi-Packs

The drug regulator has specified when combi-packs of lyophilized injections with diluents will require fresh CDSCO approval and when licenses can be issued directly by State Licensing Authorities.

Regulation | 30/09/2025 | By Dineshwori |  496