News about Quality / GMP

Innogen Wins PIC/S GMP Certification for Efsubaglutide Alfa

Innogen Pharmaceuticals has secured PIC/S GMP certification, validating its manufacturing quality and supporting the global expansion of efsubaglutide alfa.

Quality / GMP | 04/08/2026 | By News Bureau

Cipla's InvaGen Receives US FDA EIR for New York Manufacturing Facility

Cipla's subsidiary InvaGen has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA), marking the successful closure of the inspection at its New York facility.

Quality / GMP | 04/08/2026 | By News Bureau

US FDA Approves Lupin's Generic Diazepam Injection in Prefilled Syringe Format

Lupin has secured US FDA approval for its generic diazepam injection USP in a single-dose prefilled syringe format. The bioequivalent version of Roche's Valium injection expands the company's US injectable portfolio and addresses a market valued at nearly USD 78 million annually.

Quality / GMP | 04/08/2026 | By News Bureau

US FDA Approves Dr Reddy's Rituximab Biosimilar for the US Market

Dr Reddy's Laboratories has secured US FDA approval for its rituximab biosimilar, expanding its global biosimilars portfolio and strengthening its presence in the US biologics market.

Quality / GMP | 03/08/2026 | By News Bureau

Iksuda Therapeutics Secures US FDA IND Clearance for Novel ADC Candidate IKS04 in GI Cancers

Phase 1 trial to evaluate first-of-its-kind CA242-targeted antibody-drug conjugate with an innovative co-administration regimen designed to improve solid tumour penetration and therapeutic efficacy.

Quality / GMP | 03/08/2026 | By News Bureau

Aspen Neuroscience's Parkinson's Cell Therapy Receives US FDA RMAT Designation

Aspen Neuroscience has received US FDA Regenerative Medicine Advanced Therapy designation for sasineprocel (ANPD001), its investigational autologous cell therapy for Parkinson's disease.

Quality / GMP | 31/07/2026 | By News Bureau |  109

US FDA Approves Teleflex's Ezplaz Freeze Dried Plasma, First Licensed FDP in the US

Teleflex has received US FDA Biologics License Application (BLA) approval for Ezplaz Freeze Dried Plasma, the first FDA-licensed freeze-dried plasma product in the United States.

Quality / GMP | 31/07/2026 | By News Bureau

Qnovia Secures Global License for Novel Antimicrobial Peptide to Combat Drug-Resistant Infections

Qnovia has obtained worldwide exclusive rights from the University of Virginia to develop and commercialise the D8 antimicrobial peptide, a novel therapy designed to target multidrug-resistant bacterial infections through a unique mechanism.

Quality / GMP | 31/07/2026 | By News Bureau

Gland Pharma Receives US FDA Approval for Generic Sugammadex Injection

Gland Pharma has secured US FDA approval for its generic Sugammadex Injection and launched the product in the US, strengthening its injectable portfolio in a market valued at approximately USD 1.6 billion annually.

Quality / GMP | 29/07/2026 | By News Bureau

Lundbeck's Oral Narcolepsy Drug Candidate Receives FDA Fast Track Designation

Lundbeck has received FDA Fast Track designation for Lu AH69593, its investigational oral orexin 2 receptor agonist, accelerating the development of a potential new treatment for patients living with narcolepsy.

Quality / GMP | 27/07/2026 | By News Bureau