Glenmark Pharma's Maharashtra facility clears USFDA inspection

Glenmark Pharma's Maharashtra facility clears USFDA inspection


Glenmark Pharmaceuticals has announced that its formulation manufacturing facility located in Chhatrapati Sambhaji Nagar (Aurangabad), Maharashtra, has successfully cleared the US Food and Drug Administration (USFDA) inspection with zero observations

The inspection was conducted from 9 September to 20 September 2024. In conclusion, the USFDA has issued Form 483 with zero observations.

Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with presence across specialty, generics and OTC businesses.

The drug maker reported consolidated net profit of Rs 340.27 crore in Q1 FY25, significantly higher from Rs 14.48 crore in Q1 FY24. Revenue from operations increased 6.85% year on year (YoY) to Rs 3,244.19 crore in the quarter ended 30 June 2024.

 

The scrip declined 1.56% to ends at Rs 1,625.40 on Friday, 20 September 2024.

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First Published: Sep 21 2024 | 4:30 PM IST



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Glenmark Pharma's Maharashtra facility clears USFDA inspection

BHEL bags order worth over Rs 6,100-cr from NTPC


Bharat Heavy Electricals (BHEL) has announced that it has received an order worth over Rs 6,100 crore from NTPC to set up supercritical thermal power project in Chhattisgarh.

The order includes an engineering, procurement, and construction (EPC) package for the 1×800 MW Sipat supercritical thermal power project stage-III located in Bilaspur, Chhattisgarh.

The project is expected to be executed by 48 months from the date of notification of the award.

NTPC is India’s largest energy conglomerate. It has presence in the entire value chain of the power generation business. As on 30 June 2024, the Government of India holds 51.10% in NTPC.

 

State-run Bharat Heavy Electricals (BHEL) is engaged in design, engineering, construction, testing, commissioning and servicing of a wide range of products and services to the core sectors of economy. As of 30 June 2024, the Government of India held 63.17% stake in the company.

On Friday, 20 September 2024, shares of BHEL rose by 3.50% to Rs 266.15, while NTPC added 0.04% to Rs 424.15 on the BSE.

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First Published: Sep 21 2024 | 3:27 PM IST



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Glenmark Pharma's Maharashtra facility clears USFDA inspection

Aarti Drugs' Maharashtra facility gets 7 observations from USFDA


Aarti Drugs announced that the United States Food and Drug Administration (USFDA) conducted an inspection at its active pharmaceutical ingredient (API) manufacturing facility located in MIDC, Tarapur, Maharashtra.

The API inspection was conducted from 12 September to 20 September 2024. At the conclusion of the inspection, the USFDA issued a Form FDA 483, which included seven inspectional observations. Notably, none of the observations were related to data integrity.

The company stated that it will work closely with USFDA to resolve all points raised during the inspection.

Aarti Drugs is primarily involved in manufacturing and marketing of Active Pharmaceutical Ingredients (API), Pharma Intermediates and Specialty Chemicals.

 

The companys consolidated net profit declined 30.5% to Rs 33.24 crore on 16% slide in net sales to Rs 555.34 crore in Q1 FY25 over Q1 FY24.

The scrip advanced 1.16% to ends at Rs 524.80 on Friday, 20 September 2024.

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First Published: Sep 21 2024 | 2:05 PM IST



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Glenmark Pharma's Maharashtra facility clears USFDA inspection

ONGC Videsh signs new gas deal for ACG Field, Azerbaijan


ONGC Videsh acquired 2.31% participating interest in ACG project in 2013

ONGC Videsh, together with the State Oil Company of the Azerbaijan (SOCAR), bp, MOL, INPEX, Equinor, ExxonMobil, TPAO, and ITOCHU, have signed an addendum to the existing Production Sharing Agreement (PSA) for ACG Field in the Azerbaijan sector of the Caspian Sea.

The addendum amends the ACG PSA enabling the parties to progress the exploration, appraisal, development and production from the Non-Associated Natural Gas (NAG) reservoirs of the ACG field and is effective till the end of the existing ACG PSA in 2049. The NAG resources of ACG are believed to be significant, with up to 4 trillion cubic feet (tcf) in place.

 

The participating interests of the ACG co-venturers in the NAG project are the same as in the existing ACG PSA i.e., bp (30.37%), SOCAR (25.0%), MOL (9.57%), INPEX (9.31%), Equinor (7.27%), ExxonMobil (6.79%), TPAO (5.73%), ITOCHU (3.65%), ONGC Videsh (2.31%). bp remains the operator of the ACG PSA.

NAG reservoirs are multiple geological formations beneath and above the currently producing oil reservoirs, and were not initially included in the existing ACG PSA. In 2022, ACG co-venturers and SOCAR agreed to drill a data well into the NAG reservoirs to collect gas pressure data. The data well was completed in 2023, and the interpretation of the acquired data confirmed the presence of natural gas resources within the expected pressure range.

In accordance with the addendum, SOCAR and ACG co-venturers are now planning the next steps for the development of NAG reservoirs. As part of this, an initial well is planned to be drilled to produce gas from two priority reservoirs with the first gas production is expected in 2025.

ONGC Videsh acquired the Participating Interest (PI) in the ACG project in 2013.

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First Published: Sep 21 2024 | 1:07 PM IST



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Glenmark Pharma's Maharashtra facility clears USFDA inspection

Glenmark Pharma successful concludes USFDA inspection of its Aurangabad unit


Glenmark Pharmaceuticals announced that the United States Food & Drug Administration (USFDA) completed a Good Manufacturing Practice (GMP) inspection at the Company’s formulation manufacturing facility based out
of Chhatrapati Sambhaji Nagar (Aurangabad), India. The inspection was conducted from 9 September to 20 September, 2024. The inspection closed with no observation

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First Published: Sep 21 2024 | 12:53 PM IST



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Glenmark Pharma's Maharashtra facility clears USFDA inspection

Board of India Glycols approves change in directorate


At meeting held on 21 September 2024

The Board of India Glycols at its meeting held on 21 September 2024 has approved appointment of Sushil Dutt Salwan (DIN: 10776621) and Samrat Banerjee (DIN: 06706345) as Additional Directors in the category of independent directors of the Company with effect from 01 October 2024.

The Board also noted the cessation of Pradip Kumar Khaitan (DIN: 00004821), Jagmohan N. Kejriwal (DIN: 00074012), Ravi Jhunjhunwala (DIN: 00060972), and Jitender Balakrishnan (DIN: 00028320) as Independent Directors of the Company upon the completion of their second term, with effect from the close of business hours on 30 September 2024.

 

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First Published: Sep 21 2024 | 12:06 PM IST



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