INDIA – Global pharma major Lupin has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Pithampur-based facility.
Lupin has received an EIR with a Voluntary Action Indicated (VAI) status from the U.S. FDA for its facility for oral solids and ophthalmic dosage forms situated in Pithampur in the city of Indore in the heart of Madhya Pradesh.
In a press release, Lupin said: “The Establishment Inspection Report was issued post the last inspection of the facility conducted from March 21 to March 29, 2023.”
The drug maker further said that FDA inspection held from March 21 to March 29, 2023 was a surveillance inspection.
The U.S. FDA has determined that the inspection classification of the company’s Pithampur Unit-2 manufacturing facility is Voluntary Action Indicated.
According to the U.S. FDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
The U.S. Food and Drug Administration gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted scrutiny.
Moreover, the receipt of the EIR with VAI status also signifies the imminent closeout of the warning letter issued by USFDA for Lupin’s Pithampur Unit-2 manufacturing facility earlier.
Commenting on the regulatory decision, Nilesh Gupta, Managing Director of Lupin, stated: “We are pleased to have received the EIR from the US FDA with a satisfactory VAI status for our Pithampur Unit-2 facility.”
In another significant development, Lupin announced that the US Food and Drug Administration issued an EIR for its new injectable facility situated in Nagpur, India.
The company’s Nagpur Oral Solid Dosage facility received two observations with Form-483 from USFDA after closing inspection between July 3 and July 11, 2023.
“This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance. We look forward to new products approvals and launches, especially ophthalmic products from this facility now,” underscored Nilesh Gupta.
US FDA greenlights Lupin’s Chlorpromazine Hydrochloride tablets
What’s more, the company’s wholly-owned subsidiary, Lupin Inc. has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets.
Lupin Inc will manufacture Chlorpromazine Hydrochloride tablets at its facility in Somerset, New Jersey, the United States.
This product is the generic equivalent to the reference listed drug (RLD), Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg of Ups her-Smith Laboratories, LLC.
It is used to manage and treat psychotic disorders such as schizophrenia, bipolar disorder, and acute psychosis.
Lupin Inc’s Chlorpromazine Hydrochloride will be available in the form of hard capsules in the strengths of 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.
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