News about "Good Manufacturing Practices "

Concord Biotech Gujarat Plant Gets One US FDA Observation

Concord Biotech Gujarat Plant Gets One US FDA Observation

Concord Biotech’s formulation facility in Gujarat has completed a US FDA inspection with one minor procedural observation, according to the company.

Good Manufacturing Practices | 19/09/2026 | By News Bureau |  101

IP Alliance to Host 11th Advanced GMP Workshop on Quality Systems for the Next Decade

IP Alliance to Host 11th Advanced GMP Workshop on Quality Systems for the Next Decade

IP Alliance’s 11th Advanced GMP Workshop will focus on strengthening pharmaceutical quality systems amid evolving technology, manufacturing practices and regulatory requirements.

Good Manufacturing Practices | 07/09/2026 | By News Bureau |  127

Genprex Partners with US CDMO to Scale Up Diabetes Gene Therapy Manufacturing

Genprex Partners with US CDMO to Scale Up Diabetes Gene Therapy Manufacturing

Genprex has partnered with a US-based CDMO to scale up cGMP manufacturing of its AAV-based diabetes gene therapy candidate, supporting IND-enabling studies and future clinical trials.

Good Manufacturing Practices | 19/08/2026 | By News Bureau |  102

Karnataka FDA and US FDA Strengthen Regulatory Partnership to Advance Food and Drug Safety

Karnataka FDA and US FDA Strengthen Regulatory Partnership to Advance Food and Drug Safety

Karnataka FDA and the US FDA have strengthened their regulatory partnership through a strategic collaboration focused on capacity building, joint training, regulatory innovation and global best practices to enhance food and pharmaceutical quality, manufacturing compliance, and public health standards.

Good Manufacturing Practices | 23/07/2026 | By News Bureau |  169

CuraTeQ Biologics Secures ANVISA Approval for Hyderabad Biosimilars Manufacturing Facility

CuraTeQ Biologics Secures ANVISA Approval for Hyderabad Biosimilars Manufacturing Facility

CuraTeQ Biologics has received ANVISA GMP approval for its Hyderabad biosimilars manufacturing facility, strengthening its global regulatory credentials and enabling expanded supply of biosimilar products to Brazil and the wider Latin American market.

Good Manufacturing Practices | 22/07/2026 | By News Bureau |  220

Glenmark Pharma Receives Six Procedural Observations Following US FDA Inspection of Goa Facility

Glenmark Pharma Receives Six Procedural Observations Following US FDA Inspection of Goa Facility

Glenmark Pharmaceuticals has received six procedural observations in a Form 483 following a US FDA GMP inspection of its Goa manufacturing facility. The company said there were no data integrity or repeat observations and expects no impact on the supply of its commercial products while it works with the regulator to address the findings.

Good Manufacturing Practices | 02/07/2026 | By News Bureau |  739


 

 

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