Page 152 - CW E-Magazine (2-7-2024)

Pharmaceuticals Hydrocarbons

REGULATORY ACTIONS INDUSTRY TRENDS
Alembic Pharma gets USFDA fi nal approval for India’s downstream oil and gas profi ts to fall;

icatibant injection upstream to remain strong: Fitch Ratings

Alembic Pharmaceuticals announced of strengths of 30-mg/3-mL (10 mg/mL) 30-mg/3-mL (10 mg/mL), of Takeda India’s oil and gas sector is poised to remain robust, with low-single digit at ONGC’s and RIL’s offshore fi elds
that it has received fi nal approval from single-dose prefi lled syringe, stated the Pharmaceuticals U.S.A., Inc. Icatibant for a nuanced fi scal performance in percentage growth in oil and gas pro- in the Krishna-Godavari Basin, and
the US Food & Drug Administration Vadodara-based company. This is the fi rst injection has an estimated market size FY24, with anticipated declines in duction supporting strong cash fl ows. technology-driven output stabilisation
(USFDA) for its Abbreviated New peptide product approval from the USF- of $112-mn for twelve months ending downstream profi ts contrasting with Key players like ONGC, Oil India Ltd. efforts at mature fi elds. Despite this
Drug Application (ANDA) for icatibant DA received by the company. March 2024 according to IQVIA. robust upstream growth, according to (OIL), and Reliance Industries Ltd. growth, the country’s dependence on
injection used for treatment of acute Alembic has a cumulative total of 205 an analysis from Fitch Ratings. (RIL) will benefi t from elevated crude crude oil imports will likely increase,
attacks of hereditary angioedema (HAE) The approved ANDA is therapeuti- ANDA approvals (177 fi nal approvals and prices, even though they may not reach as consumption growth is set to outpace
in adults 18 years of age and older. The cally equivalent to the reference listed 28 tentative approvals) from USFDA, Fitch projects a 3-4 percent increase FY24 highs, Fitch said. domestic production.
USDFA approval is for icatibant injection drug product (RLD), Firazyr injection, the company stated. in India’s petroleum product demand
Sun Pharma receives warning letter from USFDA for the fi scal year ending in March 2025 In FY24, domestic oil and gas India’s natural gas production is
(FY25), buoyed by rising consumer, production rose by 3 percent, bolstered expected to grow by low-single digits
for Dadra facility industrial, and infrastructure needs. This by a 6 percent increase in gas output. in FY25, supported by ongoing deve-
is in tandem with an expected GDP
lopment projects at ONGC and RIL.
Sun Pharmaceuticals has received a Sun said in a stock market fi ling, adding In April, Sun had said its Dadra faci- growth of 7 percent. Diesel and petrol Fitch anticipates high capital expen- However, this growth may slow as RIL’s
warning letter from the United States Food that the contents of the letter would be lity had undergone an inspection from will continue to dominate the consump- diture (capex) levels among industry Krishna-Godavari Basin fi eld approaches
and Drug Administration (USFDA) for made public by the USFDA in due course. the USFDA from December 4, 2023 to tion landscape, accounting for over players. Upstream companies are likely peak production. LNG imports, which
its Dadra facility. “This intimation is further to our commu- December 15, 2023. The US regulator half of the overall demand, which grew to maintain high capex to drive pro- grew by 16 percent in FY24, are expec-
nication dated April 11, 2024, about the had subsequently determined the inspec- by 5 percent in FY24 and 2 percent in duction growth and ensure reserve ade- ted to rise further by mid-to-high single
“The warning letter summarises viola- Dadra facility receiving OAI (Offi cial tion classifi cation as an OAI status, it had the initial months of FY25. Indian oil quacy, while sovereign-backed down- digits in FY25 due to increased demand
tions with respect to current Good Manu- Action Indicated) status by the USFDA,” then said, adding “We will work with the marketing companies (OMCs) are anti- stream entities are set to invest heavily and moderated international gas prices.
facturing Practice (cGMP) regulations,” Sun added. regulator to achieve fully compliant status”. cipated to maintain steady market- in refining, petrochemical, and retail Petroleum product demand is projected
ing margins in FY25. However, Fitch capacity expansions. Investments in to rise by mid-single digits in FY25,
Cipla, Sun Pharma ink non-exclusive agreement with warns that rising crude prices amid energy transition initiatives are expected driven by strong growth in automobile
geopolitical uncertainties could apply to rise gradually across the sector. sales, infrastructure spending, and eco-
Takeda on acid-refl ux drug pressure on these margins. India’s crude oil production is forecasted nomic expansion. Exports of petroleum
to grow by mid-single digit percentages products rose by 2 percent in FY24
Drugmakers Cipla and Sun Pharma Disease (GERD). The drug is approved ing the treatment of erosive esophagitis The upstream segment is expected in FY25, driven by production increases after a decline in FY23.
have signed non-exclusive patent in India for treatment of adults with and Helicobacter pylori (H. pylori)
license agreements with Japan’s Takeda refl ux esophagitis and other acid peptic infection. The drug works by inhibiting PARTNERSHIP
Pharmaceutical Company Ltd., for disorders. ‘Vonoprazan’, discovered and potassium ion binding to the proton ONGC, IOC to establish LNG plant near Hatta gas fi eld
‘Vonoprazan’ for India. The drug is used developed by Takeda, was approved by pump in gastric parietal cells, reducing
to treat acid-related illnesses among the USFDA in November 2023, includ- gastric acid secretion. State-run ONGC said that it has The establishment of the Hatta The plant will utilise cutting-edge
patients. Torrent Pharma had earlier also signed a memorandum of understand- LNG plant will signifi cantly enhance technology to produce LNG, a cleaner
inked a similar agreement on the same Aarti Drugs reports fi re incident ing (MoU) with IOC to establish a the Vindhyan Basin’s status, upgrading alternative to traditional fossil fuels,
drug. at Tarapur unit small-scale Liquefi ed Natural Gas it from a Category II to a Category I signifi cantly reducing carbon emis-

The latest deal is meant to commer- Aarti Drugs has informed that a tion of the said unit has been temporarily (LNG) plant near the Hatta Gas Field Basin, the exploration & production sions and aligning with India’s climate
in the Vindhyan Basin in Madhya (E&P) major said.
change mitigation goals, ONGC added.
cialise the drug in India under Cipla’s own fi re broke out on 17 June 2024, at its disrupted. There is no loss of life or Pradesh.
trademark brands, while Sun Pharma ‘N-198’ unit located at Tarapur, injuries reported. Adequate steps are being Basins which have proven hydro- The discovery at Hatta represents
will commercialise ‘Vonoprazan’ tablets Maharashtra. The unit manufactures undertaken to restore the operation of the The ‘non-binding MoU for a Techno- carbon resources with established the culmination of fi ve decades of
10-mg, 20-mg in India under the brand certain active pharmaceutical ingredients unit,” the company informed. logy Demonstration Small Scale LNG commercial production are Category-I sustained exploration efforts. ONGC
name ‘Voltapraz’. ‘Vonoprozan’ (oral (APIs) products for external customers. plant at Hatta, Madhya Pradesh’ between basins, whereas Category-II are basins has already submitted its Field Deve-
tablets) is a novel potassium-competi- The company projects no material ONGC and Indian Oil is a visionary step with contingent resources that are yet lopment Plan (FDP) to the Directorate
tive acid blocker (P-CAB), used for the “The fi re was brought under control impact on fi nancials and operations of towards a sustainable and prosperous to be converted to recoverable reserves General of Hydrocarbons (DGH) to
treatment of Gastroesophageal Refl ux immediately. However, production opera- business. future for India, ONGC said. and commercial production. monetise its assets in the Hatta area.

152 Chemical Weekly July 2, 2024 Chemical Weekly July 2, 2024 153

Contents Index to Advertisers Index to Products Advertised