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Results For "quality-standards"

165 News Found

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2
Drug Approval | July 18, 2025

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2

The company is addressing these observations comprehensively


SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally
Drug Approval | July 17, 2025

SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally

The receipt of EIR reaffirms the company's commitment to maintaining global quality standards


Veerhealth Care enters into contract manufacturing agreement
News | July 08, 2025

Veerhealth Care enters into contract manufacturing agreement

Commercial production is expected to begin soon


SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services
Drug Approval | June 27, 2025

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations


BASF opens new GMP Solution Center in US
News | June 23, 2025

BASF opens new GMP Solution Center in US

BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America


DuPont adds sterile packaging capacity of healthcare manufacturing site in Costa Rica
News | June 07, 2025

DuPont adds sterile packaging capacity of healthcare manufacturing site in Costa Rica

The 16,000-square-foot expansion enhances DuPont’s global sterile operations


Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP
Drug Approval | May 24, 2025

Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP

Allopurinol is used to prevent or lower high uric acid levels in the blood


Venus Remedies secures Ukrainian GMP renewal
News | May 23, 2025

Venus Remedies secures Ukrainian GMP renewal

Certification bolsters Venus Remedies' position in PIC/S markets, reinforcing commitment to global quality standards


Remedium Lifecare secures Rs. 182.7 crore export deal
News | May 16, 2025

Remedium Lifecare secures Rs. 182.7 crore export deal

The CDMO upgrade represents a transformational step for Remedium Lifecare


Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site
Drug Approval | May 06, 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