News about "Indoco Remedies"

Indoco Remedies Receives Seven Form 483 Observations Following US FDA Inspection

Indoco Remedies’ Plant 2 (Sterile) facility in Goa received seven Form 483 observations following a USFDA inspection conducted from August 27 to September 4, 2026.

Indoco Remedies | 08/09/2026 | By News Bureau |  161

Indoco Remedies Reports Improved Q1 FY27 Revenue and EBITDA

Indoco Remedies reported higher revenue and improved EBITDA in Q1 FY27, supported by the strong performance of its domestic formulations business and steady progress in international formulations and APIs.

Indoco Remedies | 28/07/2026 | By News Bureau

Indoco Remedies Secures EU GMP Certification for Baddi Formulation Plant III

Indoco Remedies has received EU GMP certification for its Baddi Plant III formulation facility following a successful inspection conducted in April 2026.

Indoco Remedies | 28/05/2026 | By News Bureau |  276

Indoco Remedies Clears Malta Medicines Authority Audit

Indoco Remedies receives EU GMP certification from the Malta Medicines Authority, validating compliance with European Good Manufacturing Practice (GMP) standards.

Indoco Remedies | 15/05/2026 | By News Bureau |  122

Indoco Remedies Transfers Ophthalmic Division to Sunways India

Indoco Remedies transfers its ophthalmic business in India and select African markets to Sunways India under a strategic business transfer agreement to strengthen portfolio focus and growth.

Indoco Remedies | 02/05/2026 | By News Bureau |  480

Indoco Remedies Secures US FDA Approval for Generic Brivaracetam Oral Solution

Indoco Remedies receives US FDA approval to market generic brivaracetam oral solution for partial-onset seizures in the US market.

Indoco Remedies | 24/02/2026 | By News Bureau |  218

Indoco Receives USFDA EIR for Patalganga API Manufacturing Facility

Indoco has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration for its API manufacturing facility at Patalganga following an inspection conducted in the month of September.

Indoco Remedies | 15/12/2025 | By News Bureau |  186

USFDA Completes Inspection of Indoco API Plant in Patalganga with Zero Observations

The inspection of Indoco’s API manufacturing facility at Patalganga by the US FDA concluded with zero form 483 observations.

Indoco Remedies | 22/09/2025 | By Dineshwori |  255

Indoco Remedies Signs Sale and Lease Agreement with OPC Asset Solution

Indoco has signed an agreement with OPC Asset Solution for the sale and subsequent leaseback of certain movable properties at its Waluj Facility in Aurangabad and its AnaCipher Clinical Research Organisation (CRO) in Hyderabad, Telangana.

Indoco Remedies | 30/08/2025 | By Dineshwori |  297

Indoco Secures EU GMP Compliance Certificate for its Sterile Drug Product Manufacturing Facility in Goa - Plant II

Indoco Remedies Ltd. has received EU GMP certification from the European Health Authorities for its sterile drug manufacturing facility located in South Goa – Goa Plant II.

Indoco Remedies | 24/07/2025 | By Mrinmoy Dey |  401