Tag: US FDA

USFDA issues inspection report for Lupin’s Aurangabad manufacturing facility

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Drug maker Lupin Ltd on Tuesday (April 23) said it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Aurangabad manufacturing facility.

The inspection was conducted from March 6 to March 15, 2024. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI), Lupin said in a regulatory filing.

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Nilesh Gupta, managing director of Lupin, said, “We are pleased to receive the EIR with VAI status from the US FDA as an outcome of the recent inspection of our Aurangabad facility.

It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide.”

Shares of Lupin Ltd ended at ₹1,580.55, down by ₹26.25, or 1.63% on the BSE.

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Lupin launches first generic version of Oracea skin treatment capsules in US

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Drug maker Lupin Ltd on Tuesday (April 9) said it has launched the first generic version of Oracea (doxycycline capsules, 40 mg) in the United States.

This milestone follows the company’s approval from the United States Food and Drug Administration (US FDA) for the product, Lupin said in a regulatory filing.

Doxycycline capsules, 40 mg is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients, Lupin mentioned.

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According to estimates, doxycycline capsules, 40 mg had annual sales of approximately $128 million in the US market as of February 2024, the company added.

Lupin reported a 299.6% year-on-year (YoY) jump in net profit at ₹613.1 crore for the third quarter that ended December 31, 2023. In the corresponding quarter last year, Lupin posted a net profit of ₹153.4 crore.

The company’s revenue from operations increased 20.2% to ₹5,197.4 crore against ₹4,322.2 crore in the corresponding period of the preceding fiscal. At the operating level, EBITDA jumped 95% to ₹1,037.9 crore in the third quarter of this fiscal over ₹532.2 crore year-on-year.

Also Read: Lupin targets $250 million in quarterly US sales in 3-4 years

The EBITDA margin stood at 20% in the reporting quarter against 12.3% in the corresponding period in the previous fiscal. EBITDA is earnings before interest, tax, depreciation, and amortisation. CNBC-TV18 poll had predicted a margin of 17% for the quarter under review.

Shares of Lupin Ltd ended at ₹1,605.00, down by ₹7.65, or 0.47%, on the BSE.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

US FDA raises a concern after Lupin’s Aurangabad unit inspection

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Indian pharma major Lupin Ltd on Friday (March 15) disclosed that its manufacturing facility located in Aurangabad underwent inspection by the US Food and Drug Administration (FDA) from March 6-15, 2024.

The inspection concluded with the issuance of a Form-483, highlighting one observation.

“We would like to notify you that the U.S. FDA inspected Lupin’s manufacturing facility at Aurangabad from March 6 to March 15, 2024. The inspection closed with the issuance of a Form-483 with one (1) observation,” according to a stock exchange filing.

While the specifics of the observation were not detailed in the announcement, Lupin expressed confidence in its ability to address the concerns raised by the FDA promptly.

“We are confident of addressing the concern raised by the US FDA and will resolve the same at the earliest. We uphold quality and compliance with utmost importance and are committed to comply with CGMP quality standards across all our facilities,” Lupin said.

What is a Form 483

A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors after the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference.

However, Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance. After Form 483 is issued, the company is given 15 days to submit its response to the USFDA, explaining what steps it will take to resolve the observations made by the USFDA.

Shares of Lupin Ltd ended at ₹1,639.65, down by ₹9.85, or 0.60%, on the BSE.

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Sun Pharma recalls 55,000 bottles of generic drug from US market due to manufacturing norms violation

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Drug major Sun Pharma is recalling around 55,000 bottles of a generic medication to treat gout from the US market due to manufacturing practices norms deviations, according to the US health regulator.

The New Jersey-based unit of the Mumbai-based drug major is recalling Febuxostat Tablets in 40 mg and 80 mg strengths, US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

Sun Pharmaceutical Industries Inc. is recalling 47,520 bottles (40mg) and 7,488 bottles (80 mg) respectively of the medication due to Current Good Manufacturing Practice regulations (CGMP) deviations, it stated.

“Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment,” the USFDA stated.

The affected lot was produced at Sun Pharma’s Dadra-based plant for Memphis-based Northstar Rx LLC, the US regulator noted.

Febuxostat is used to lower uric acid levels in people with gout.

As per the USFDA, the company has initiated the Class II nationwide (US) recall on March 4 this year.

As per the USFDA, a class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Sun Pharma is one of the leading generic pharmaceutical companies in the US. The US generic drug market was estimated to be around $115.2 billion in 2019. It is the largest market for pharmaceutical products.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Suven Pharmaceuticals receives US FDA nod for Hyderabad units

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Suven Pharmaceuticals Ltd on Friday (February 23) said the US Food & Drug Administration (US FDA) has completed the pre-approval inspections (PAI) and good manufacturing practices (GMP) inspections at the company’s facilities in Hyderabad.

“This is to inform you that our Active Pharmaceutical Ingredients (API) and Formulations facilities (Unit-3 and Unit-5, respectively) in Pashamylaram, Hyderabad, India, have completed the Pre-Approval Inspections (PAI) and Good Manufacturing Practices (GMP) inspections by the US Food & Drug Administration (US FDA) today,” the company said, according to a stock exchange filing.

The inspections, conducted between February 12-23, 2024, have concluded successfully, with no Form 483 issued by the FDA. “The inspection was conducted from February 12, 2024, to February 23, 2024, and we are pleased to inform you that no Form 483 has been issued as a result of the inspection,” the company said.

Suven Pharmaceuticals’ net profit dropped 56.6% year-over-year (YoY) to ₹46.5 crore in the quarter ended December 2023. The company’s net profit stood at ₹107.7 crore in Q3 of FY24.

The company’s revenue also dropped 37.9% to ₹219.8 crore in the third quarter of the current fiscal. Suven Pharma had posted ₹353.8 crore in the corresponding period of the previous fiscal.

The pharma company’s earnings before interest, taxes, depreciation and amortisation (EBITDA) also dipped 55.6% to ₹65.2 crore in the quarter ended December 2023 against ₹146.7 crore in the year-ago period.

Shares of Suven Pharmaceuticals Ltd ended at ₹668, up by ₹2.60, or 0.39%, on the BSE.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Lupin gains on USFDA approval for generic anti-pregnancy drug

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Lupin Ltd’s shares gained 2% on Friday (February 16) after the company announced receiving approval from the United States Food and Drug Administration (USFDA) for a generic drug to prevent pregnancy.

The leading global pharma company, in a filing to the stock exchanges, said that it has received approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for Minzoya tablets. The Minzoya tablets are used by women of reproductive potential to prevent pregnancy, the company informed the bourses.

Minzoya (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate tablets) is a generic equivalent of Balcoltra (Levonorgestrel and Ethinyl Estradiol tablets, USP, and Ferrous Bisglycinate tablets), the company said. The product will be manufactured at the company’s Pithampur facility in Madhya Pradesh.

The US health regulator has approved the launch of Minzoya tablets in the dosage of 0.1 mg/0.02 mg and 36.5 mg. Levonorgestrel and Ethinyl Estradiol Tablets, USP, and Ferrous Bisglycinate Tablets are estimated to have annual sales of over $42 million in the US, according to IQVIA MAT December 2023 data.

The new approval comes days after Lupin launched the Ganirelix Acetate Injection in the United States. The injection is used in fertility treatment in women.

The company had received USFDA approval to launch the injection in the dosage of 250 mcg/0.5 mL, in a single-dose prefilled syringe. The Ganirelix Acetate Injection is a generic equivalent of Ganirelix Acetate Injection in the same dose.

Lupin’s share prices have maintained a steady upward trend since the announcement of its performance report for the quarter ending in December 2023.

The company has reported a 299.6% year-on-year (YoY) spike in its net profit. From ₹153.4 crore in Q3FY23, Lupin’s net profit rose to ₹613.1 crore in the third quarter of the current financial year. The company’s revenue from operations also jumped 20.2% to ₹5,197.4 crore in Q3FY24 from ₹4,322.2 crore in the year-ago period.

Shares of Lupin Ltd were trading 1.27% higher at ₹1,625.55 apiece, up 1.27%, on BSE at 2:30 PM.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Lupin gets tentative USFDA nod for rivaroxaban tablets used to treat blood clots

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pharma major Lupin received tentative approval from the United States Food and Drug Administration (USFDA) for rivaroxaban tablets on Tuesday, January 23.

Following the approval, the company released a statement, “(We) received tentative approval from the USFDA for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, to market a generic equivalent of Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc.”

The medicine, which has been tentatively approved by the USFDA, serves as a generic equivalent to Xarelto Tablets by Janssen Pharmaceuticals, Inc.

Rivaroxaban, which is used to prevent blood clots from forming due to an irregular heartbeat, will be manufactured at the company’s Pithampur facility in Madhya Pradesh.

Rivaroxaban tablets USP (RLD Xarelto®) had estimated annual sales of $8,249 million in the US as per IQVIA MAT November 2023. 

The medicine is used for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), in addition to reducing the risk of stroke, DVT, PE and recurrent VTE in paediatric patients from birth to less than 18 years, among a few other ailments.

Rivaroxaban tablets USP (RLD Xarelto®) had estimated annual sales of $8,249 million in the US as per IQVIA MAT November 2023, the company added.

Lupin has 15 manufacturing sites, seven research centres, and more than 20,000 professionals working globally, the company revealed.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Lupin reports three USFDA approvals in less than a week

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The US Food and Drug Administration has approved Propranolol Hydrochloride Extended-Release Capsules (the generic version of Inderal sold by Minnesota-based ANI Pharmaceuticals) made by Lupin, the company said in a filing to the stock exchanges.

This new medicine helps in lowering blood pressure, relaxes the blood vessels in the brain and can prevent migraine headaches. This drug had an annual sales of $71 million in the US, according to data shared by the Mumbai-based drug maker.

It will release the drug (generic Inderal) in four strenghts: 60 milligram (mg), 80 mg, 120 mg, and 160 mg. This is third new launch announced by the company in the last one week.

The other two being Varenicline tablets (recommended in the treatment of smoking addictions and dry eye disease), and bromfenac ophthalmic solution (used to treat inflammation and pain among patients who have undergone cataract surgery).

Shares of Lupin have rallied over 84% in the last one year. In the first fortnight of 2024, investors in Lupin have seen their wealth go up by nearly 6%.

The company is targetting quarterly sales of $250 million in the next 3-4 years, global chief financial officer Ramesh Swaminathan told CNBC-TV18 in an interview on January 4.

In the financial year ending March 2023, the drug maker reported a revenue of $632 million from the US (out of a total revenue of $2 billion).

In the latest second quarter ended September 2023, for the first time in two years, Lupin crossed $200 million in revenue from North America, which made for 38% of the company’s total revenue.

Aside from the new drug approvals, Lupin shares are also cheering the easing stress on the company’s profit margin.

Despite being the third largest pharmaceutical company in the US (by prescriptions), increased competition, and rising cost of inputs, had squeezed the profit margin in recent years.

However, the growing belief on the street is that the margin squeeze is now over. In the first half of the current financial year ending March 2024, the company clocked an EBITDA margin of 19% compared to just 9% in the same period last year.

Global investment bank Nomura increased the target price on Lupin share to ₹1,593 from ₹1,290 per share earlier citing better earnings potential.

Earlier, on December 28, the Mumbai-based broking firm upgraded the rating on Lupin to ‘buy’ with a new target price of ₹1,440.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Lupin’s conjunctivitis eye drop loteprednol etabonate gets USFDA approval

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pharma major Lupin Ltd on Wednesday (December 27) said it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for loteprednol etabonate ophthalmic suspension, 0.2%.

“…regarding receipt of U.S. FDA approval for the company’s Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.2%, to market a generic equivalent to the reference listed drug Alrex® Ophthalmic Suspension, 0.2%, of Bausch & Lomb Inc,” according to a stock exchange filing.

This newly-approved medication serves as a generic equivalent to the reference listed drug (RLD) Alrex® Ophthalmic Suspension, 0.2%, by Bausch & Lomb Inc.

Loteprednol etabonate ophthalmic suspension, 0.2%, is specifically indicated for the temporary relief from the signs and symptoms associated with seasonal allergic conjunctivitis, offering a crucial solution for individuals grappling with allergic reactions affecting their eyes.

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Manufactured at Lupin’s state-of-the-art facility in Pithampur, India, this milestone approval opens the door for increased accessibility to an effective treatment for seasonal allergic conjunctivitis.

The product has estimated annual sales of $29.1 million in the US, according to IQVIA MAT October 2023, the company added.

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs (active pharmaceutical ingredients) in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company has 15 manufacturing sites, seven research centres, and more than 20,000 professionals working globally.

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Shares of Lupin Ltd ended at ₹1,289, up by ₹6.25, or 0.49%, on the BSE.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Zydus Lifesciences Ahmedabad facility receives 6 observations in recent USFDA inspection

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Drug firm Zydus Lifesciences Ltd on Friday (December 22) said its active pharmaceutical ingredient (API) site located at Changodar, Ahmedabad, underwent an inspection by the United States Food and Drug Administration (USFDA) from December 14 to December 22, 2023.

The inspection, which encompassed Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP), concluded with the issuance of six observations, according to a stock exchange filing.

“This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023. The inspection closed with 6 observations. There were no Data Integrity related observations. There are no repeat observations from the previous inspection,” the drugmaker said.

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Zydus Lifesciences said it is working closely with the USFDA to promptly address the observations and ensure adherence to regulatory standards. The API site in Changodar, Ahmedabad, currently has 4 Drug Master Files (DMFs) under approval with the USFDA, the company added.

Shares of Zydus Lifesciences Ltd ended at ₹679.70, up by ₹8.80, or 1.31%, on the BSE.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow