Indoco's Goa Plant II & III clears USFDA inspection
The USFDA inspected Indoco’s Sterile facility (Plant II) and Solid Dosages facility (Plant III) situated at L-32/33/34 Verna Industrial Estate, Goa from November 14-21, 2018. The inspection concluded with Indoco receiving two minor observations, none of which are repeat. This facility had received a Warning Letter from the USFDA in March 2017.
The company is in the process of responding to the observations within the stipulated time of 15 days. The EIR will be issued by the USFDA subsequently.
“This positive development will now pave the way for approval of our pending ANDAs with consequent boost to revenues from the US market. Indoco is committed to its philosophy of highest quality in manufacturing, operations, systems integrity and cGMP culture,” said Ms. Aditi Kare Panandikar, Managing Director of Indoco Remedies Ltd.
You May Interested In
Glow70/KLOW80 99% China Peptides Warehouse Direct Delivery Lyophilized Powder in Stock
$1.8E+2/UNIT FOB
2026-09-02
Trade Alert
Delivering the latest product trends and industry news straight to your inbox.
(We'll never share your email address with a third-party.)
Related News
-
EPA Pressures Minnesota to Tackle Nitrate Threat in Drinking Water
-
FDA Proposes Nationwide Ban on Brominated Vegetable Oil (BVO) in Food Additives, Continues Safety Assessment of Chemicals
-
USDA-FSIS Initiates Year-Long Survey of Dioxins in Cattle, Swine, and Catfish Starting November
-
New Advance Notification Guidelines for Imported Foods Released by the United States
-
The world's first octreotide capsule was approved by the FDA!
-
Vera’s New Kidney Drug Wins FDA Approval, Carrying a $425,000 Annual Price
-
South Korea Expands Mandatory GMO Labeling to Highly Processed Foods
-
Bayer and Syngenta Score Consecutive Regulatory and Legal Wins in the U.S.
-
Four Fine Chemical Units of Huajin Aramco Project – HDPE, EO/EG, etc. – Reach Mechanical Completion
-
China Releases 15th Five-Year Carbon-Peaking Action Plan, Pushing Coal Chemicals into a Mandatory Low-Carbon Upgrade Cycle
Recommend Reading
-
![U.S. Exempts Critical Chemical Manufacturers from Emissions Rules for Two Years]()
U.S. Exempts Critical Chemical Manufacturers from Emissions Rules for Two Years
-
![EPA Clears Backlog of Refinery Biofuel Waivers, Sparking Fears for Ethanol Demand]()
EPA Clears Backlog of Refinery Biofuel Waivers, Sparking Fears for Ethanol Demand
-
![关于将二氟乙咪酯等16种物质列入《非药用类麻醉药品和精神药品目录》的公告 Announcement on the Inclusion of 16 Substances including Difluoroetomidate in the Catalogue of Non-Medicinal Narcotic Drugs and Psychotropic Substances]()
关于将二氟乙咪酯等16种物质列入《非药用类麻醉药品和精神药品目录》的公告 Announcement on the Inclusion of 16 Substances including Difluoroetomidate in the Catalogue of Non-Medicinal Narcotic Drugs and Psychotropic Substances
-
![Global Butadiene Market Faces Heavy Headwinds as Supply Surge Outpaces Demand]()
Global Butadiene Market Faces Heavy Headwinds as Supply Surge Outpaces Demand
-
![FDA Slows Two Natural Color Approvals, but the Additive Shift Is Still Moving]()
FDA Slows Two Natural Color Approvals, but the Additive Shift Is Still Moving
-
![Business Society’s August 27, 2026 Butadiene Market Outlook: Volatile]()
Business Society’s August 27, 2026 Butadiene Market Outlook: Volatile
-
![November Butadiene Rubber Market Trend Fluctuates and Declines in China]()
November Butadiene Rubber Market Trend Fluctuates and Declines in China
-
![Business Society’s Market Outlook for Maleic Anhydride on September 1, 2026: Volatile]()
Business Society’s Market Outlook for Maleic Anhydride on September 1, 2026: Volatile
-
![Poor cost support leads to a sharp decline in PTA prices]()
Poor cost support leads to a sharp decline in PTA prices
-
![Business Society’s Market Outlook for Phthalic Anhydride on August 27, 2026: Deep Correction Favors a Bearish View]()
Business Society’s Market Outlook for Phthalic Anhydride on August 27, 2026: Deep Correction Favors a Bearish View
