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Alembic Pharma Panelav API Manufacturing Facility

Sector: Manufacturing (Industrial) • Location: Panelav, Gujarat, India

Source: Samco

Project
Under Regulatory Review

Alembic Pharma's API-I & II manufacturing facility at Panelav, Gujarat underwent a routine USFDA inspection focused on current Good Manufacturing Practices (cGMP). The inspection resulted in four observations issued via Form 483, all of which the company considers addressable. Alembic Pharma plans to respond to the USFDA within the prescribed timeline while continuing its operations and product ap

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Project Information

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The project “Alembic Pharma Panelav API Manufacturing Facility” is an infrastructure initiative in the Manufacturing (Industrial) sector, located in Panelav, Gujarat, India. Taiyo aggregates data on it from Samco.

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Participants

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Status

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under regulatory review

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Description

Description

Alembic Pharma's API-I & II manufacturing facility at Panelav, Gujarat underwent a routine USFDA inspection focused on current Good Manufacturing Practices (cGMP). The inspection resulted in four observations issued via Form 483, all of which the company considers addressable. Alembic Pharma plans to respond to the USFDA within the prescribed timeline while continuing its operations and product approvals.

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Original Currency

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Source

Source reliability

High

Data quality score

100%

Source

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URL

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