Eir

In July, Suven Pharma had received a Form 483 from USFDA, with two observations regarding Casper Pharma, which the company said were procedural in nature, assuring these would be addressed in stimulated time.

Lupin Mandideep plant gets green signal from USFDA

The US Food and Drug Administration (USFDA) issues an EIR to a company when an inspection is satisfactorily closed.

Aurobindo Pharma gets EIR from USFDA for its Andhra Pradesh facility

The company's Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing facility.

Lupin's Somerset manufacturing plant receives EIR from US FDA

The US Food and Drug Administration (US FDA) had inspected the facility in March 2022, the company said in a regulatory filing.

Lupin's Mandideep Unit II facility receives EIR from USFDA

In a filing to BSE, the company said Lupin has received the EIR after closure of the USFDA inspection of its Mandideep Unit II facility, classifying the inspection as "Voluntary Action Indicated."

Lupin gets EIR from USFDA for Nagpur plant

The health regulator had inspected the company's Nagpur manufacturing facility between January 6 and January 10, 2020, Lupin Ltd said in a statement.

Biocon's insulin manufacturing facility in Malaysia gets EIR with VAI classification From USFDA

In a regulatory filing the company said, Biocon Sdn Bhd, a subsidiary of Biocon Ltd has received the EIR from the USFDA for the Pre-Approval Inspection (PAI) of its insulin manufacturing facility in Malaysia, for Insulin Glargine.

Lupin gets EIR from USFDA for Florida-based inhalation research centre

The facility was inspected by the US Food and Drug Administration (USFDA), between February 19, 2020, and February 26, 2020, on behalf of the UK Medicines and Healthcare Products Regulatory Agency (UKMHRA) for company's application for generic Fostair.

Marksans Pharma gets EIR from USFDA for New York unit

In a regulatory filing, the company announced "receipt of the EIR from US Food and Drug Administration (USFDA) in respect of inspection of company's manufacturing facility Time-Cap Laboratories Inc. located at Farmingdale, New York, USA carried out from December 5, 2019 to December 18, 2019".

J B Chemicals gets EIR from USFDA for unit in Gujarat

The company has received EIR from the United States Food and Drug Administration (US FDA) for its newly set up and commissioned solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat, J B Chemicals and Pharmaceuticals said in a regulatory filing.

Cadila Healthcare gets EIR from USFDA for its Ahmedabad facility

The company's topical manufacturing facility at Ahmedabad has received an EIR from the United States Food and Drug Administration (USFDA) signifying the successful closure of the audit, Cadila Healthcare said in a filing to the BSE.

Cipla gets EIR from USFDA for Invagen manufacturing facility

"Following the inspection by the United States Food and Drug Administration (USFDA) at the lnvagen (US) manufacturing facility from December 2, 2019 to December 6, 2019, the company has received the establishment inspection report (EIR), indicating closure of the inspection," Cipla said in a filing to BSE.

Strides arm receives EIR for its US facility

Strides Pharma Inc received EIR from the United States Food and Drug Administration (USFDA) for the inspection conducted at its unit it December last year.

Shilpa Medicare gets EIR from USFDA for Raichur facility

An EIR is given to a unit on successful closure of an inspection conducted by the United States Food and Drug Administration (USFDA).

Cadila Healthcare gets EIR from USFDA for Baddi facility

"The company's formulations manufacturing facility located at Baddi, India, has received an EIR. The United States Food and Drug Administration (USFDA) had conducted an inspection at the facility from July 15 to 19, 2019," Cadila Healthcare said in a filing to BSE.

Lupin gets EIR from USFDA for Nagpur facility

The United States Food and Drug Administration (USFDA) conducted the inspection between August 5-8, 2019, Lupin said in a filing to the BSE. The inspection for the oral solid facility closed without any Form 483 observation, it added. Form 483 notifies the company's management of objectionable conditions.

Strides Pharma Science gets EIR for Bangalore facility

"The company's formulations facility (KRSG Gardens) in Bangalore which was inspected by the US Food and Drug Administration (USFDA) in August 2018 and November 2018, has received the Establishment Inspection Report (EIR), thereby confirming the successful closure of the inspections," Strides Pharma Science said in a BSE filing.

Dr Reddy's gets EIR from USFDA for 2 units at Medak

In an earlier filing to the bourses on March 9, the drug firm had said it had received five observations from the US Food and Drug Administration (USFDA) for its API Hyderabad plant 3 at Medak district.

SMS Pharmaceuticals gets EIR for Bachupally facility

The company's manufacturing facility at Bachupally, Hyderabad, has received EIR from the United States Food and Drug Administration (USFDA), SMS Pharmaceuticals said in a filing to the BSE.

Natco Pharma receives EIR from USFDA, stock up 1.05%

Natco Pharma announces successful EIR from the US Food and Drug Administration (USFDA) for the inspection conducted at its drug manufacturing facility in Kothur village in Mahabubnagar district during January 16–24, 2017, the company said in a BSE filing today.

Alkem Labs gets EIR from USFDA for Ankaleshwar plant

Drug firm Alkem Laboratories today said it has received establishment inspection report (EIR) from the US health regulator on the closure of its inspection at its API facility at Ankaleshwar in Gujarat.

Dishman Pharma receives EIR report from USFDA

"The company's Bavla facility was successfully inspected by the USFDA in July, 2016, which was intimated to the stock exchanges on July 9, 2016. In this regard, the company has received the Establishment Inspection Report (EIR) from the USFDA for this facility on February 1, 2017," Dishman Pharma said in a regulatory filing.

Lupin receives EIR report from USFDA for Goa plant

The company said it has received notification that the inspection carried out by the USFDA in March 2016 at its Goa facility is now closed and the agency has issued an Establishment Inspection Report (EIR).

Drug co Caplin Point eyes US foray by 2018-end

Caplin Point Laboratories should be able to foray into the US market by end of 2018, says Chief Promoter and Chairman CC Paarthipan in an interview to CNBC-TV18.

Data integrity issues hamper relations with regulators: Strides

In an interview to CNBC-TV18, Arun Kumar, Founder & MD of Strides Shasun says that the pharma industry lacks trust now as more and more issues with regulators come to light.