DRL Andhra Pradesh facility gets 3 observations from USFDA

DRL Andhra Pradesh facility gets 3 observations from USFDA


Dr Reddy’s Laboratories said that the US drug regulator has issued Form 483, with three observations after inspecting its Andhra Pradesh manufacturing facility.

According to the exchange filing the United States Food & Drug Administration (USFDA) has completed a product-specific Pre-Approval Inspection (PAI) at its formulations manufacturing facility in Srikakulam, Andhra Pradesh.

The said inspection was conducted from 19 August 2024 to 23 August 2024. Following the inspection, the USFDA has issued a Form 483 with three observations. The company has committed to addressing these observations within the stipulated timeline.

Dr Reddy’s Labs is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products.

The companys consolidated net profit shed marginally to Rs 1,392.40 crore in Q1 FY25 as against 1,405 crore posted in Q1 FY24. However revenue from operations jumped 13.9% YoY to Rs 7,672.70 crore in Q1 FY25.

The scrip shed 0.28% to settle at Rs 6,953.20 on Friday, 23 August 2024.

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First Published: Aug 24 2024 | 2:50 PM IST



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DRL Andhra Pradesh facility gets 3 observations from USFDA

Alembic Pharmaceuticals receives USFDA approval for Betamethasone Valerate Foam


Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam, 0.12%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Luxiq Foam, 0.12%, of Norvium Bioscience, LLC (Norvium).

Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp. Refer label for a detailed indication.

Alembic has a cumulative total of 213 ANDA approvals (185 final approvals and 28 tentative approvals) from USFDA.

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First Published: Aug 24 2024 | 2:03 PM IST



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DRL Andhra Pradesh facility gets 3 observations from USFDA

Zydus Life arm inks pact to acquire 50% stake in Sterling Biotech


Zydus LIfesciences said that its wholly owned subsidiary, Zydus Animal Health and Investments has entered into share purchase and share subscription agreement (SPSSA) with Perfect Day to acquire 50% stake in Sterling biotech.

Sterling Biotech is one of the leading producers of Pharmaceutical Gelatine, Di-calcium phosphate and some APIs. It operates 2 (two) manufacturing facilities in Gujarat. Its turnover was Rs 454.89 crore for FY24.

The company will acquire 32.16 crore equity shares of Rs 1 each for total consideration of Rs 550 crore subject to certain adjustments with respect to cash and debt.

Perfect Day Inc., a Temasek portfolio company will sell its around 50% shareholding in Sterling Biotech. Post this transaction, Sterling Biotech will become a 50:50 joint venture (JV) with equal representation on the board.

The JV will establish a manufacturing facility to manufacture fermented animal free protein to cater to the global markets. The JV will accelerate the production of high-quality and ecofriendly protein products, reduce environmental impact, and cater to the growing consumer demand for fermentation-based and ethically sourced nutrition.

The acquisition will also mark Zydus foray into specialised biotech products for health and nutrition, specifically catering to consumers who prefer animal-free protein or suffer from lactose intolerance. Perfect Days precision-fermented protein is found in ice creams, cream cheese, sports nutrition products, and baked goods with high functionality benefits and lower environmental impact.

The said acquisition of sale shares is expected to be completedwithin perion of 60 working days from date of execution of the SPSSA.

Dr. Sharvil Patel, managing director, Zydus Lifesciences, said, We are dedicated to promoting growth through partnerships and are consistently exploring new collaborations to position India as a premier global supply chain hub. We are excited to join forces with Perfect Day and create a win-win combination that leverages both our strengths and expertise to create value for the consumers.

Narayan TM, Interim CEO, Perfect Day said, This partnership allows Perfect Day to significantly boost its capabilities to meet the demands of the fast-growing global market. We deeply value our collaboration with Zydus and believe this joint venture will allow both parties to benefit from each other’s expertise.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The pharma companys consolidated net profit surged 30.64% to Rs 1,419.9 crore in Q1 FY25 as compared to Rs 1,086.9 crore posted in Q1 FY24. Revenue from operations jumped 20.77% year on year (YoY) to Rs 6,207.5 crore in the quareter ended 30 June 2024.

The counter declined 2.57% to ends at Rs 1,178.65 on Friday, 23 August 2024.

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First Published: Aug 24 2024 | 1:52 PM IST



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DRL Andhra Pradesh facility gets 3 observations from USFDA

Data Infrastructure Trust consolidated net profit declines 29.50% in the June 2024 quarter


Sales rise 24.87% to Rs 3492.60 crore

Net profit of Data Infrastructure Trust declined 29.50% to Rs 242.80 crore in the quarter ended June 2024 as against Rs 344.40 crore during the previous quarter ended June 2023. Sales rose 24.87% to Rs 3492.60 crore in the quarter ended June 2024 as against Rs 2797.00 crore during the previous quarter ended June 2023.

ParticularsQuarter EndedJun. 2024Jun. 2023% Var.Sales3492.602797.00 25 OPM %6.9340.41 PBDT242.10732.10 -67 PBT242.10345.30 -30 NP242.80344.40 -30

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First Published: Aug 24 2024 | 1:48 PM IST



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DRL Andhra Pradesh facility gets 3 observations from USFDA

Rakan Steels standalone net profit declines 50.00% in the June 2024 quarter


Sales decline 57.69% to Rs 2.56 crore

Net profit of Rakan Steels declined 50.00% to Rs 0.01 crore in the quarter ended June 2024 as against Rs 0.02 crore during the previous quarter ended June 2023. Sales declined 57.69% to Rs 2.56 crore in the quarter ended June 2024 as against Rs 6.05 crore during the previous quarter ended June 2023.

ParticularsQuarter EndedJun. 2024Jun. 2023% Var.Sales2.566.05 -58 OPM %0.390.50 PBDT0.010.03 -67 PBT0.010.03 -67 NP0.010.02 -50

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First Published: Aug 24 2024 | 1:48 PM IST



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DRL Andhra Pradesh facility gets 3 observations from USFDA

E I T A India standalone net profit declines 25.74% in the June 2024 quarter


Sales decline 14.40% to Rs 133.34 crore

Net profit of E I T A India declined 25.74% to Rs 0.75 crore in the quarter ended June 2024 as against Rs 1.01 crore during the previous quarter ended June 2023. Sales declined 14.40% to Rs 133.34 crore in the quarter ended June 2024 as against Rs 155.78 crore during the previous quarter ended June 2023.

ParticularsQuarter EndedJun. 2024Jun. 2023% Var.Sales133.34155.78 -14 OPM %0.850.65 PBDT1.131.01 12 PBT1.131.01 12 NP0.751.01 -26

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First Published: Aug 24 2024 | 1:48 PM IST



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