Tag: Aurobindo Pharma

Aurobindo Pharma shares drop amid 3 USFDA observations to company’s Eugia Sterile unit

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

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Aurobindo Pharma shares dropped more than 2% on Monday after the United States Food and Drug Administration (USFDA) issued Form 483 to the company’s Eugia Sterile unit with three critical observations.

The US drug regulator’s observations come following an inspection conducted at the unit from March 28 to April 5, according to Form 483 accessed by CNBC-TV18.

During the inspection, the USFDA team found shortcomings in key areas of the plant’s operations, raising concerns about the adequacy of procedures to prevent microbiological contamination of drug products.

Additionally, the review highlighted a lack of verification processes for data accuracy and the absence of established control procedures.

Aurobindo Pharma is expected to address these observations promptly to ensure compliance with regulatory requirements and maintain the integrity of its manufacturing operations.

The company’s response to the Form 483 observations will be closely monitored by regulators and industry stakeholders as they work to uphold standards of quality and safety in the pharmaceutical industry.

Earlier this month, Aurobindo Pharma announced that USFDA conducted an inspection of its newly operational injectable facility in Andhra Pradesh from March 28 to April 5. The inspection closed with three observations.

The facility is managed by Eugia Steriles Private Ltd, which is a subsidiary of Eugia Pharma Specialities Ltd which in turn is a step-down subsidiary of Aurobindo Pharma.

Last month, Aurobindo Pharma Ltd announced that it has received final approval from the USFDA to produce and sell mometasone furoate monohydrate nasal spray, 50mcg/spray.

Aurobindo now holds a combined total of 507 ANDA approvals from the USFDA, comprising 488 final approvals and 19 tentative approvals.

Shares of Aurobindo Pharma were trading 0.86% lower at ₹1,078.2 apiece on the BSE at 11:25 am.

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Aurobindo Pharma arm gets 3 observations from US FDA after Andhra unit inspection

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

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Aurobindo Pharma Ltd on Friday (April 5) said the United States Food and Drug Administration (US FDA) has conducted an inspection of its newly operational injectable facility in Andhra Pradesh.

The facility is operated by Eugia Steriles Private Ltd, a subsidiary of Eugia Pharma Specialities Ltd and a stepdown subsidiary of Aurobindo Pharma. The inspection, conducted from March 28 to April 5, 2024, resulted in the issuance of three observations by the regulatory body, Aurobindo said in a regulatory filing.

“The new injectable facility of Eugia Steriles Private Limited (a 100% subsidiary of Eugia Pharma Specialities Limited and a step-down subsidiary of the Company), situated at Parawada Mandal, Anakapalli District, Andhra Pradesh, has recently started the commercial operations,” the drug maker said.

Also Read: Aurobindo Pharma confirms CNBC-TV18 newsbreak, says inspection ongoing at Unit 4

According to Aurobindo Pharma, the observations made by the US FDA are procedural in nature and will be addressed within the stipulated timeframe.

“The United States Food and Drug Administration (US FDA) inspected the above-mentioned facility from March 28, 2024 to April 05, 2024. The inspection closed with 3 observations. The observations are procedural in nature and will be responded to within the stipulated time,” the company added.

Shares of Aurobindo Pharma Ltd ended at ₹1,123.75, down by ₹0.20, or 0.018%, on the BSE.

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Aurobindo Pharma gets US FDA final approval for nasal spray to treat allergies

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

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Drug firm Aurobindo Pharma Ltd on Tuesday (March 19) said the company has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market mometasone furoate monohydrate nasal spray, 50 mcg/spray.

This nasal spray is deemed bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nasonex nasal spray, 50 mcg/spray, marketed by Organon LLC. The product will be launched in Q1FY25, according to a stock exchange filing.

Mometasone furoate monohydrate nasal spray, 50 mcg/spray, is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and paediatric patients aged two years or older, the company added.

Aurobindo now has a total of 507 ANDA approvals (488 final approvals and 19 tentative approvals) from the US FDA.

Aurobindo Pharma reported a 90.6% year-on-year rise in consolidated net profit to ₹936.2 crore for the October-December quarter of the current financial year. The company reported a profit of ₹491.2 crore in the same period last year. The revenue from operations in Q3FY24 came in at ₹7,351.7 crore, up 14.7% from the year-ago quarter numbers of ₹6,407 crore.

The company’s earnings before interest, taxes, depreciation and amortisation (EBITDA) came in at ₹1,601. crore, up from ₹954.4 crore in the year-ago period. The EBITDA margin was at 21.8% against 14.9% in the year-ago period.

Shares of Aurobindo Pharma Ltd ended at ₹990.55, down by ₹26.90, or 2.64%, on the BSE.

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Aurobindo Pharma shares jump over 3% as USFDA completes inspection at Telangana unit with zero observations

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

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Aurobindo Pharma shares jumped more than 3.5% on Friday, February 16, after the pharma company said the United States Food and Drug Administration (USFDA) completed the inspection at the manufacturing unit of its synthetic peptides active pharmaceutical pngredient (API) business arm, Auro Peptides Ltd in Telangana.

The USFDA’s inspection had zero observations, Aurobindo Pharma said in a stock exchange filing.

Aurobindo Pharma said the US regulator conducted an audit at the Auro Peptides’ manufacturing unit from February 12 to February 16, 2024.

The manufacturing unit of the company is located at the Indrakaran Village of Kandi Mandal in the Sangareddy District of Telangana.

The pharmaceutical company has come under regulatory scrutiny recently as its formulation manufacturing facility, Eugia Unit III, is likely to be facing compliance issues.

The US health regulator issued nine observations in an inspection conducted at the Eugia Unit III plant from January 22 to February 2, 2024.

As per industry experts, these observations pointed out by the USFDA indicate problems with paperwork and procedures. The key concerns raised in this 26-page Form 483 range from issues such as the lack of established procedures to prevent microbiological contamination of drugs purporting to be sterile, to incomplete lab records, and inadequate validation of aseptic processes.

Shares of Aurobindo Pharma were trading 1.39% higher at ₹1,029.25 apiece on BSE at 2:18 pm.

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Aurobindo Pharma under USFDA scrutiny: What investors need to know

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

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Aurobindo Pharma has come under the regulatory spotlight in the past two weeks as the company’s formulation manufacturing facility, Eugia Unit III, could be facing compliance issues. The US Food and Drug Administration (USFDA) issued nine observations after inspecting the Eugia Unit III plant from January 22 to February 2.

The plant is a part of Aurobindo Pharma’s speciality business, Eugia Pharma Specialities. The latest development is that the US federal regulator issued nine observations to the plant that manufactures sterile drugs such as injectables and ophthalmics.

According to experts, the observations point to problems with paperwork and procedures. The key concerns raised in this 26-page Form 483 range from issues such as the lack of established procedures to prevent microbiological contamination of drugs purporting to be sterile, to incomplete lab records, and inadequate validation of aseptic processes.

Observations point to deficiencies in manufacturing practices and investors fear if there were questions around the data generated by the facility.

Aurobindo, in response to these findings, has taken proactive measures. The company announced during a recent call that it would submit its response on Eugia Unit 3 by February 26. Moreover, as a cautionary step, manufacturing operations in some lines at Eugia Unit 3 have been halted.

However, the company expects to resume non-aseptic line production in a few weeks and aseptic line production within a month. Unit 3 contributes significantly to Aurobindo’s Eugia business, which accounts for 40% of the company’s total revenue.

Aurobindo anticipates a potential impact of $20 million in the fourth quarter due to the shutdown of operations at Eugia Unit 3. However, the company does not anticipate major pending approvals from Eugia Unit III in FY25–26. Aurobindo anticipates sales from new launches in the near term to be between $35 and $40 million, with new launches from Eugia Unit 3 accounting for 50%, or approximately $20 million.

Despite these challenges, Aurobindo remains confident of achieving its 20% margin target, with growth in FY25–26 to be mainly driven by the Revlimid generic.

Analysts say the next port of call will be the company’s response to the observations and the USFDA’s classification of the plant, which is expected within three months of the inspection. If the plant is classified as an ‘official action indicated’, then the regulator could take adverse steps such as a warning letter that stops future approvals. In the worst-case scenario, it can issue an ‘import alert’ that stops all current manufacturing and future approvals.

In the event of an import alert, it could impact consolidated EBITDA by 15%, according to Elara, which maintains its buy call with a target price of ₹1,208.

Amid these developments, Aurobindo’s stock has corrected by around 16% since February 1, resulting in a reduction in the FY25 PE ratio to 14.7x, down from 17x on January 31.

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Aurobindo Pharma gets USFDA approval for muscular dystrophy tablets

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

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Aurobindo Pharma Limited shares closed higher on Monday after the company announced receiving the approval from the United States Food and Drug Administration (USFDA) for Deflazacort Tablets.

In a filing to the stock exchanges, the company said that the US drug regulator has issued approval for Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg.

Deflazacort Tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and above.

The approved drug has an estimated market size of $67 million for the three months ending September 2023, according to PTC Therapeutics Inc, the company informed the bourses.

The company now has a total of 502 ANDA approvals including 20 tentative approvals from USFDA.

Headquartered in Hyderabad, Aurobindo Pharma develops manufactures, and commercialises a wide range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients (APIs) globally in over 150 countries.

The company owns 25 manufacturing and packaging facilities, approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.

Aurobindo Pharma shares showed strong consolidation on Monday, rallying over 3% in intraday trade after the company posted strong Q3 results.

The company’s net profit soared nearly 91% year-on-year to ₹936.2 crore for the December quarter. Its revenue was up by 14.7% YoY to ₹7, 351.7 crore.

The pharma company’s operational performance also improved as the EBITDA margin expanded to 21.8% from 14.9% in the year-ago period.

Aurobindo Pharma shares closed higher at ₹1,017.95 apiece, up 1.59%, on BSE.

ALSO READ | Aurobindo Pharma unit to sell business assets to Empower for $52 million plus lease payments

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

Aurobindo Pharma unit to sell business assets to Empower for $52 million plus lease payments

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

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Eugia US Manufacturing LLC, USA, a wholly-owned step-down subsidiary of Aurobindo Pharma Ltd. has signed an asset purchase agreement with Empower Clinic Services New Jersey, LLC to dispose of its business assets as a going concern for $52 million, Aurobindo Pharma said in an exchange filing on Monday.

The deal will also involve Eugia’s related assets, liabilities and employees since capacities and operations are being ramped up in other units of the company. Once the deal is closed, it will enter into contract manufacturing arrangements with the buyer.

A cash consideration of $52 million will be received from the disposal of the assets. An additional $58 million will also be made as lease payments to Eugia US Manufacturing LLC and / or its affiliates, over the 20-year lease term, including extensions.

The transaction is expected to close within 90 days from the date of agreement, subject to fulfilment of closing conditions referenced in the definitive agreement, including financial closure by the buyer.

Aurobindo Pharma will also be in focus after the USFDA concluded the inspection at Unit-III of Eugia Pharma and issued nine observations to the facility. As a result, the company has decided to temporarily stop manufacturing on certain lines to conduct a holistic investigation and corresponding partial distribution.

The company further said that it has already started working with the regulator and third-party consultants to accelerate the process of restarting production at the earliest.

As of now, Aurobindo Pharma does not see a material impact on the business due to this move. The inspection at Unit-III, which is a formulations manufacturing facility was conducted between January 22 to February 2, 2024.

Shares of Aurobindo Pharma have been flat so far this year, but have gained nearly 160% over the last 12 months.

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

Aurobindo Pharma confirms CNBC-TV18 newsbreak, says inspection ongoing at Unit 4

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

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Drugmaker Aurobindo Pharma Ltd. responded to CNBC-TV18’s exclusive newsbreak, stating that the USFDA inspection of Eugia-III, the erstwhile Unit IV of Aurobindo Pharma, the formulation manufacturing facility of Eugia, is under progress from January 22.

The company added that the inspection has not been concluded yet.

“As per the usual and standard practice, after the inspection is concluded, Aurobindo Pharma intimates the stock exchanges regarding the outcome, including the number of observations, if any, and the same will be followed for the ongoing inspection also,” the company said.

Earlier in the day, CNBC-TV18 had reported citing sources that drugmaker Aurobindo Pharma’s Unit 4, which is the company’s injectables facility is currently being inspected by the United States Food & Drug Administration.

Aurobindo Pharma’s Unit 4 is part of Eugia Pharma Specialities, which is the company’s injectables arm. The unit in question was transferred to Eugia Pharma Specialities in 2021 on a going concern basis.

The Eugia Unit III was formerly known as Unit IV and manufactures injectables and opthalmics.

The unit in question has 105 drugs with final approval, four with tentative approval and 31 drugs which are under review.

Shares of Aurobindo Pharma are trading 7.1% lower at ₹1,068. This is the biggest single-day drop for the stock since November 2022.

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Aurobindo Pharma subsidiary receives CDSCO nod for breast cancer treatment drug

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

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Aurobindo Pharma Ltd’s wholly-owned subsidiary, CuraTeQ Biologics Private Ltd, on Wednesday,January 17, received marketing authorisation from the Central Drugs Standard Control Organization (CDSCO) for biosimilar trastuzumab.

In a stock exchange filing, Aurobindo Pharma said that CureTeQ Biologics received a recommendation for grant of marketing authorisation of biosimilar trastuzumab from the Subject Experts Committee (SEC) of CDSCO, the apex drug regulator in India.

Trastuzumab biosimilar is a humanised monoclonal antibody that is used in the treatment of metastatic breast cancer and early breast cancer.

This monoclonal antibody is supplied in single dose glass vials that contain lyophilized powder in the dosages of 150 mg and 420 mg as concentrate for solution for infusion, Aurobindo Pharma informed the bourses.

CuraTeQ was asked to submit Phase IV clinical trial protocol to CDSCO within three months of receiving the marketing authorisation.

Earlier this month, Aurobindo Pharma’s manufacturing facility located in Sangareddy district of Telangana, was classified as ‘voluntary action indicated’ after inspection by the United States Food and Drug Administration (USFDA).

In another development, Aurobindo Pharma is reportedly exploring the options for the launch of initial public offering (IPO) of its wholly-owned subsidiary, speciality generic firm Eugia Pharma Specialities, to raise around ₹4,500 crore in 2024.

The Hyderabad-based company had previously attempted the sale of Eugia and held discussions with top private equity players in 2022, but the negotiations did not fructify into an eventual deal due to differences over valuations.

Shares of Aurobindo Pharma were trading 2.3% lower at ₹1,093.35 per piece on BSE at 12:50pm.

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Aurobindo Pharma now weighs mega IPO of Eugia Pharma Specialities to raise around ₹4,500 crore

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

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Aurobindo Pharma is in value unlocking mode again, and is now exploring a big-bang initial public offer (IPO) of its wholly-owned subsidiary — speciality generic firm Eugia Pharma Specialities — to raise around ₹4,500 crore in 2024, multiple industry sources told Moneycontrol.

The Hyderabad-based parent had previously attempted the sale of Eugia and held discussions with top private equity players in 2022, but the negotiations did not fructify into an eventual deal due to differences over valuations.

“With the markets in a buoyant phase and pharma valuations looking attractive, Aurobindo Pharma is now evaluating a listing of Eugia. The deal was kicked off recently with all the advisors,” said one of the persons above.

A second person told Moneycontrol that the plan is to raise around ₹4,500 crore via the proposed IPO. He added that investment banks Axis Capital, Jefferies, Kotak Mahindra Capital and JP Morgan had been shortlisted as advisors along with three law firms. Three other persons also confirmed the above.

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“The plan has shifted to the public markets where there is an ongoing wave of new issues. These are early days and the aim is to raise between ₹4,000 crore to ₹5,000 crore via the listing,” one of them said, warning that the quantum had not been finalized and may change later depending on market conditions

All the five persons cited above spoke to Moneycontrol on the condition of anonymity. Moneycontrol has sent reminders and is awaiting the response to a detailed email query sent to Aurobindo Pharma.

This article will be updated as soon as we hear from the pharma major. An immediate response could not be elicited from Axis Capital, Kotak Mahindra Capital, Jefferies and JP Morgan.

The domestic pharma and life sciences sector has been active in terms of public issues in the last 8 months. Last month, Bain Capital-backed Emcure Pharma re-filed papers with Sebi for an initial public offer with a reduced size.

Mankind Pharma galvanized the domestic IPO market last year with a blockbuster debut in May. It was followed by healthy debuts in the segment from Concorde Biotech, Blue Jet Healthcare and Innova Captab.

Eugia rejig: The Aurobindo Pharma strategy

In a disclosure to the bourses on August 25, Aurobindo Pharma said, “The company has already informed the stock exchanges on August 12, 2023, as part of the outcome of its board meeting that it is in the process of exploring all the possibilities of restructuring the business of Eugia Pharma Specialities Limited, a wholly owned subsidiary company focused on sterile/injectables, oncology and hormonal products.”

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“And as stated earlier, the Committee of Independent Directors will pursue a comprehensive evaluation of various alternatives or options and recommend to the Board for engendering the next horizon of growth as also enhancing value creation to the stakeholders,” it added.

The statement was a clarification of a report by The Economic Times, which said Eugia Pharma had been put on the block once again. Incidentally, Aurobindo Pharma’s stock price has risen by more than 50% in the last six months.

In May 2021, in a move to improve operational efficiency, the pharma firm approved the transfer of its injectable assets into Eugia Pharma Specialities Limited for “greater focus, attention and specialization” and also to “augment fundraise and strategic tie-ups in future through joint ventures etc” according to exchange disclosures.

According to Aurobindo Pharma’s latest annual report, Eugia Pharma, a speciality generic pharmaceutical company, has six manufacturing units located in different locations in India and the US.

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The units contribute to the production of a diverse range of differentiated and unique products such as general injectables, oncology, hormonal, penems, penicillin and ophthalmics. According to the Eugia website, the firm is present in 120 plus countries and has 4,000 plus employees and 250 plus globally approved generics.

Eugia’s parent parent Aurobindo Pharma was founded in 1986 by P.V. Ramprasad Reddy, K. Nityananda Reddy and a small group of professionals.

According to the firm’s website, in addition to being a leading player in semi-synthetic penicillin, Aurobindo Pharma has a presence in key therapeutic segments such as neurosciences (CNS), cardiovascular (CVS), anti-retroviral, anti-diabetics, gastroenterology and anti-biotics.

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