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Special Report

Manufacturing & supply lines: Small-molecule APIs
MANUFACTURER & EXPORTER

mall-molecule drugs still dominate ment over 2022 levels, which represented PATRICIA VAN ARNUM A GMP, ISO ( 9001:2015, 14001:2015 and 45001:2018), FSSAI, HALAL & KOSHER CERTIFIED COMPANY
new drug approvals, as measured a recent low in small-molecule drug ap- Editorial Director AVAILABLE IN GRADE : IP/BP/USP/EP/FCC
Sby the number of new molecular provals. The decrease in small molecules’ Drug, Chemical & Associated
entities approved by the FDA’s Center share of new drug approvals in 2022 was • ALUMINIUM SULPHATE Cas.7784-31-8 • MAGNESIUM SULPHATE 7H2O Cas.10034-99-8 • SODIUM PHOSPHATE DIBASIC
for Drug Evaluation and Research, but are largely due to the overall decline in new Technologies Association,Inc. (DCAT) • AMMONIUM MOLYBDATE Cas.12054-85-2 • MAGNESIUM SULPHATE DRIED CAS.7487-88-9 HEPTAHYDRATE CAS.7782-85-6
• SODIUM PHOSPHATE DIBASIC DIHYDRATE
• AMMONIUM PHOSPHATE Cas.7783-28-0
• MAGNESIUM SULPHATE ANHYDROUS CAS.
they translating into market success? drug approvals in 2022 and a correspond-  Astellas’ Veozah (fezolinetant) for re- • BISMUTH SUBCARBONATE Cas.5892-10-4 7487-88-9 CAS.10028-24-7
DCAT Value Chain Insights takes a look ing decline in small-molecule drug ap- ducing moderate-to-severe vasomotor • BISMUTH SUBNITRATE CAS.1304-85-4 • MAGNESIUM OXIDE CAS 1309-48-4 • SODIUM PHOSPHATE DIBASIC
on the market for drugs with small-mole- provals and a rise in new biologic drug symptoms due to menopause; • BENZOIC ACID CAS.65-85-0 • POTASSIUM BI CARBONATE CAS.298-14-6 MONOHYDRATE CAS.118830-14-1
cule active pharmaceutical ingredients approvals. In 2022, FDA’s CDER ap-  AstraZeneca’s Truqap (capivasertib) • BORAX SODIUM BORATE CAS.1330-43-4 • POTASSIUM BI SULPHATE CAS.7646-93-7 • SODIUM PHOSPHATE TRIBASIC
and related supply-demand fundamen- proved 22 new small-molecule drugs and for treating advanced HR-positive • BORIC ACID CAS.10043-35-3 • POTASSIUM CARBONATE CAS.584-08-7 DODECAHYDRATE CAS.10101-89-0
tals. 15 new biologics. The 17 new biologics breast cancer; • CALAMINE CAS 8011-96-9 • POTASSIUM CHLORIDE CAS.7440-09-7 • SODIUM PHOSPHATE TRIBASIC ANHYDROUS
CAS.7601-54-9
• POTASSIUM NITRATE CAS.7757-79-1
• CALCIUM CARBONATE CAS.471-34-1
approvals in 2023 surpassed 2022 levels  Bausch and Lomb’s Miebo (perﬂ uoro- • CALCIUM CHLORIDE DIHYDRATE CAS. • POTASSIUM IODIDE CAS.7681-11-0 • SODIUM NITRITE CAS.7632-00-0
Overall new drug approvals in 2023 and matched a recent high in 2018, when hexyloctane ophthalmic solution) for 10035-04-8 • POTASSIUM PHOSPHATE MONOHYDRATE • SODIUM SULPHATE CAS 7757-82-6
Last year (2023) saw an uptick in new 17 new biologics were also approved by treating dry-eye disease; • CALCIUM SULPHATE CAS.7778-18-9 CAS.7778-77-0 • SODIUM SULPHITE CAS.7757-83-7
drug approvals compared to 2022, which FDA’s CDER. The 17 new biologic drug  Biogen’s Qalsody (tofersen) for treating • CALCIUM PHOSPHATE DI BASIC DIHYDRATE • POTASSIUM PHOSPHATE DIBASIC CAS. • STANNOUS CHLORIDE CAS 10025-69-1
was a recent dip in new drug approvals. approvals in 2023 far exceeded approvals amyotrophic lateral sclerosis (ALS, CAS 7789-77-7 7758-11-4 • SALICYLIC ACID CAS.69-72-7
The US Food and Drug Administration’s of new therapeutic biologics by FDA’s i.e., Lou Gehrig’s disease); • CALCIUM PHOSPHATE DI BASIC ANHYDROUS • POTASSIUM SODIUM TARTRATE CAS 6381-59-5 • SODIUM SELENITE PENTAHYDRATE
• POTASSIUM SULPHATE CAS.7778-80-5
CAS.7757-93-9
CAS.26970-82-1
Center for Drug Evaluation and Research CDER of 14 in 2021, 13 in 2020, and 10  GlaxoSmithKline’s Jesduvroq (da- • CALCIUM PHOSPHATE TRIBASIC CAS 7758-87-4 • POTASSIUM BROMIDE CAS.7758-02-03 • UREA CAS.57-13-6
(CDER) approved 55 new molecular enti- in 2019. produstat) for treating anaemia due to • CUPRIC SULPHATE PENTAHYDRATE CAS • SODIUM BI CARBONATE CAS .144-55-8 • ZINC CARBONATE CAS.3486-35-9
ties (NMEs) and new therapeutic biologics chronic kidney disease; 7758-99-8 • SODIUM FLUORIDE CAS .7681-49-4 • ZINC OXIDE CAS 1314-13-2
in 2023, a 49% increase in the number of Small-molecules and ﬁ rst-in-class drugs  Novartis’ Fabhalta (iptacopan) for • CUPRIC SULPHATE ANHYDROUS CAS.7758-98-7 • SODIUM MONOFLUORO PHOSPHATE CAS. • ZINC SULPHATE HEPTAHYDRATE CAS.
new drug approvals compared to 2022, Aside from just the overall number treating paroxysmal nocturnal haemo- • COPPER CARBONATE CAS.12069-69-1 10163-15-2 7646-20-0
when 37 new drugs were approved. The of new drug approvals, product innova- globinuria, a rare blood disorder; • CUPRIC CHLORIDE CAS.10125-13-0 • SODIUM NITRATE CAS 7631-99-4 • ZINC SULPHATE MONOHYDRATE CAS.
7446-19-7
• FERROUS SULPHATE DRIED CAS.13463-43-9
• SODIUM PHOSPHATE MONOBASIC DIHYDRATE
55 new drugs approved in 2023 by FDA’s tion can also be evaluated by the num-  Novo Nordisk’s Rivﬂ oza (nedosiran) • FERROUS SULPHATE HEPTAHYDRATE CAS. CAS.13472-35-0 • ZINC CHLORIDE CAS. 7646-85-7
CDER was in line with recent years. In ber of new drug approvals classiﬁ ed as for treating primary hyperoxaluria, a 7782-63-0 • MAGNESIUM PHOSPHATE DI BASIC CAS • MAGNESIUM PHOSPHATE TRIBASIC CAS.
2021, 50 NMEs and new therapeutic bio- “ﬁ rst-in-class,” which FDA’s CDER rare condition characteriwed by recur- • MANGANESE SULPHATE MONOHYDRATE CAS. 7782-75-4 • SODIUM PHOSPHATE MONOBASIC 7757-87-1
logics were approved by FDA’s CDER characterizes as drugs with a different rent kidney and bladder stones; and 10034-96-5 ANHYDROUS CAS.7558-80-7
and 53 in 2020. The 55 new drugs ap- mechanism of action than existing drugs.  Pﬁ zer’s Paxlovid (nirmatrelvir tablets; • MANGANESE CHLORIDE CAS. 13446-34-9 • SODIUM PHOSPHATE DIBASIC ANHYDROUS
proved in 2023 represented the second In 2023, FDA’s CDER approved 20 new ritonavir tablets, co-packaged) for • MAGNESIUM CARBONATE Cas.546-93-0 CAS.7558-80-7
highest level of approvals in the past drugs that it characterized as ﬁ rst-in- treating COVID-19. • MAGNESIUM CHLORIDE HEXAHYDRATE • SODIUM PHOSPHATE DIBASIC
Cas.7791-18-6
DODECAHYDRATE CAS.10039-32-4
decade, except for 2018 when 59 new class, which represented approximately
drugs were approved. 36% of new drug approvals. Of these Although small-molecule drugs were SPECIAL PRODUCTS WE MAKE IN OUR FACTORY
20 ﬁ rst-in-class new drug approvals, 17 well represented with 85% of the ﬁ rst-in-
Small-molecule new drug approvals were small molecules, representing 85% class new drug approvals in 2023, more POTASSIUM DICHROMATE LR BORIC ACID POWDER AR
In 2023, FDA’s CDER approved 38 of ﬁ rst-in-class new drug approvals in than half of these drugs were for niche POTASSIUM CHROMATE LR POTASSIUM PHOSPHATE LR /AR
small-molecule products, representing 69% 2023 by FDA’s CDER. Of these 17 ﬁ rst- indications. Of the 17 small-molecule STARCH (POTATO SOLUBLE) LR SODIUM NITRATE LR /AR
of new drug approvals (see Figure 1). in-class, small-molecule new drug ﬁ rst-in-class drug approvals in 2023, COPPER SULPHATE ANHYDROUS LR SODIUM CARBONATE ANHYDROUS (GRANULAR)
The percentage of small-molecule ap- approvals in 2023, eight were from large nine, or 53%, were for treating orphan/ FOR CATALOGUE COMPANIES IN LR GRADE
provals in 2023 was in line with recent to mid-sized bio/pharma companies. rare diseases, deﬁ ned as a disease affect-
year, except in 2022, which represented a These eight drugs were: ing 200,000 individuals or less in the US. BISMUTH NITRATE / SUBNITRATE / OXIDE / OXYCHLORIDE / SULPHATE / CARBONATE
recent low. In 2022, 59% of the new drug IODIDE OF AMMONIUM / CADMIUM / LEAD / BARIUM/STRONTIUM
approvals by FDA’s CDER were small NICKEL / SULPHATE / CHLORIDE / CARBONATE / NITRATE / AMMONIUM SULPHATE
molecules or 22 of the 37 new drug ap- 69% 59% 72% 75% 79% STRONTIUM / BROMIDE / CARBONATE / CHLORIDE / NITRATE / SULPHATE
provals. Between 2018 and 2021, small QUALIKEMS LIFESCIENCES PVT. LTD.
molecules averaged 74% of new drug
approvals. In 2021, small molecules re- 2023: 55 new 2022: 37 new drugs 2021: 50 new drugs 2020: 53 new 2019: 48 new drugs H.O & WORKS: Plot No.68-69, G.I.D.C Industrial Estate, Nandesari,
presented 72% of new drug approvals, 75% drugs approved; 38 approved; 22 small approved; 36 small drugs approved; 40 approved; 38 small Vadodara - 391340 (GUJARAT).
small molecules
small molecules
molecules
molecules
molecules
in 2020, and 79% in 2019.
Fig. 1: Percentage of new drug approvals by the US FDA’s CDER that were small molecules Telefax : + 91-265-2841531,32,34,35 • Mobile: +91-92275 36999
Small molecule approvals are NMEs approved via a New Drug Application (NDA) by the CDER; NDA Email: salesindia@qualikems.com & Info@qualikems.com
The 69% of new drug approvals being approvals include drugs and diagnostic agents.
small molecules in 2023 was an improve- Source: CDER Web : www.qualikems.com
KNS ADI
180 Chemical Weekly June 18, 2024
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