Last Updated : Monday, May 11, 2020 21:20:49

Tag Archives: EIR

IND-SWIFT LABS’ Derabassi (Punjab) cleared by USFDA, gets EIR

CHANDIGARH / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Chandigarh headquartered pharmaceutical products manufacturing Indian company Ind-Swift Laboratories Ltd said of having got Establishment Inspection Report (EIR) from USFDA (US Food and Drugs Administration) for its Derabassi plant located in the state of Punjab, in India. In

USFDA inspects Biocon’s Malaysian facility, issues EIR with VAI classification

BANGALORE / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bengaluru headquartered Indian bio-technology company Biocon Ltd said of having got Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAI) for the company’s Malaysian facility, engaged in manufacturing insulin. The company statement attributed to the company spokesperson, titled,

STRIDE PHARMA’s Banglore facility gets EIR

BANGALORE / MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bangalore headquartered Stride Pharma Science Ltd said of having got Establishment Inspection Report (EIR) for their Bangalore facility after the facility was inspected by USFDA (US Food and Drugs Administration) in the month of January 2020, for specific

USFDA inspection @ AUROBINDO PHARMA’s Unit IV continues …

HYDERABAD | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Hyderabad headquartered Aurobindo Pharma Ltd said of the USFDA inspection still open and under review of the company’s Unit IV, as per the communication received from the US Food and Drugs Administration, as per the previous communication, the

USFDA clears STRIDES PHARMA’s Florida (US) facility, issues EIR

MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical products manufacturing company Strides Pharma Science Ltd said of its Florida (US) based facility, having got cleared by USFDA (US Food and Drugs Administration) post inspection and the facility has got Establishment Inspection Report. The press-release titled,

HIKAL’s Panoli (Gujarat) plant gets EIR, with zero observations

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical company Hikal Ltd said of its Panoli (Gujarat) facility being inspected successfully by USFDA (US Food and Drugs Administration) and the facility has received establishment inspection report (EIR) with zero observations. In a filing as submitted

INDOCO REMEDIES’ CRO – AnaCipher receives EIR from USFDA

HYDERABAD | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory updates submitted to the Indian Stock Exchanges, Hyderabad headquartered Indoco Remedies Ltd’s Clinical Research Organization (CRO) has been inspected by USFDA (US Food and Drugs Administration) and cleared being granted Establishment Inspection Report (EIR). In a press-release as submitted by the company to the

USFDA inspects INDOCO REMEDIES’ Goan plants gives EIR

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered Indoco Remedies Ltd said of its Goan plants inspected and having received Establishment Inspection Report (EIR). In a press-release submitted to the Indian Bourses, titled – “Indoco receives EIR for its manufacturing facilities in Goa (Plant II

SeQuent Scientific’s Bengaluru facility gets Establishment Inspection Report

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered pharma company SeQuent Scientific Ltd said of its Bengaluru facility getting clearance post inspection by US FDA (Food & Drugs Administration) and getting Establishment Inspection Report (EIR). The press-statement submitted by the company -titled, “SeQuent Scientific receives

USFDA clears Indoco Remedies’ Goa Plant II & III, despite four 483 observations

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Bourses, Mumbai headquartered Indoco Remedies said of its Goa plant inspected by US FDA (Food & Drugs Administration) and the plant – II & III have been cleared, despite the fact that company had received four 483 observations. The press release

USFDA inspects Lupin Pharma’s Mumbai facility, slam 4 observations

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – USFDA (US Food & Drugs Administration) inspected the Mumbai facility of Lupin Pharma and has issued Establishment Inspection Report to the site & facility inspected.  The Regulators have also slammed 4 observations post inspecting the Lupin’s Mumbai facility In a regulatory filing submitted to the Indian Exchanges,  Pharma major

Cipla’s Goa units gets EIR after being inspected by USFDA

MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, pharma major Cipla Ltd said United States Food and Drug Administration (USFDA) at the Goa manufacturing facility from 21st – 28th January, 2019, the Company has received the Establishment Inspection Report (EIR), indicating closure of the inspection. For more details, please click the

USFDA concludes Cadila Healthcare’s (Zydus) Pharmez facility with one observation

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, on Wednesday, Ahmedabad headquartered Pharma major Cadila Healthcare (Dr Pankaj Patel led Zydus Cadila Group) Ltd said of one of their units being inspected by US Food & Drugs Administration (USFDA) and the regulator has concluded the inspection with one

Wockhardt’s Shendra (Aurangabad) facility gets inspected by EU Regulators

MUMBAI | RAJKOT – In a regulatory update filed to the Indian Stock Exchanges, Wockhardt Ltd said of European Regulators having successfully inspected Shendra (Aurangabad) facility of the company and granting needed licenses for manufacturing medicines from inspected facility. For more details, click the link, given here : https://buff.ly/2HZ5fNU  Follow DATELINE GUJARAT On :-Facebook, Google+, Linkedin, Twitter, YouTube, Blogspot, Telegram, Instagram SHARE

USFDA inspects Strides Pharma’s Bengaluru facility, gets EIR with Zero 483 Observations

BANGALURU | MUMBAI | RAJKOT – US FDA (Food & Drugs Administration) successfully inspected Strides Pharma Sciences Ltd’s formulations facility (KRSG Gardens) in  Bengaluru and the facility has  received the Establishment Inspection Report (EIR), there by confirming the successful  closure of the inspections, the company said in Press Release submitted to the Indian Stock Exchanges

Zydus Biologics (of Zydus Cadila Group) inspected successfully by US FDA

AHMEDABAD | MUMBAI | RAJKOT – In a press-release submitted to the Indian Bourses, Cadila Healthcare Ltd (Dr Pankaj Patel led Zydus Cadila Group) said of one of the company’s subsidiary facilities being inspected successfully by US Food & Drug Administration. The Company’s Biologics manufacturing facility (Zydus Biologics) located at the Zydus Biotech Park in

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