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Arch Pharmalabs Ltd., Thane, India – FDA Inspections

Inspection records and compliance data for Arch Pharmalabs Ltd. in Thane. 5 FDA inspections on record, 2 Form 483s, last inspected September 12, 2025.

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Company Profile

This profile covers Arch Pharmalabs Ltd. based in Thane, India.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
4
NAI
0
Unclassified
1
Form 483s
2
Warning letters
0

First inspected December 5, 2009. Last inspected September 12, 2025.

FDA inspections (5)

DateResultFDA center(s)Insp. #
September 12, 2025Not classifiedHuman Drugs1288012
May 25, 2018VAIHuman Drugs · Drug Quality Assurance1055379
January 29, 2016VAIHuman Drugs · Drug Quality Assurance956907
May 3, 2013VAIHuman Drugs · Drug Quality Assurance833403
December 5, 2009VAIHuman Drugs · Drug Quality Assurance662652
FDA documents

Form 483s (1)

  • Form 483s · September 12, 2025
People (1)
Christopher R. Czajka
Person
Related Companies (10)

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Natco Pharma Ltd. - Chemical Division
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Aarti Pharmalabs Limited
Jiangxi Synergy Pharmaceutical, Co., Ltd.
Zhejiang Cheng Yi Pharmaceutical Co., Ltd.
Zach System S.A.
Wuhan Biocause Pharmaceutical Development Co., Ltd.
Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)
Albemarle US, Inc.
Somerville Acquisitions, Inc.
Company Information

Name

Arch Pharmalabs Ltd.

FEI Number

3002808114

Address

Plot C21-22 & F40 Midc, Phase 2, Sagaon, Dombivli, Thane, India

Country

India

ID: 2766781c-7a1a-4718-bb0e-04fa9616a574

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