2. Amoxicillin
▪ Amoxicillin is in a class of medications called
penicillin-like antibiotics. It works by stopping the
growth of bacteria. Clavulanic acid is in a class of
medications called beta-lactamase inhibitors. It
works by preventing bacteria from destroying
amoxicillin.
▪ Amoxicillin. Amoxicillin is an oral semi-synthetic
penicillin, moderate-spectrum, bacteriolytic,
lactam antibiotic used to treat bacterial infections
caused by susceptible microorganisms by which it
is susceptible to the action by the β-lactamases.
3. Process of Manufacturing
• Existing process of Amoxicillin trihydrate 6-APA.TEA Salt reacts
with Mixed Anhydride to give N-protected amoxicillin. The N-
protected amoxicillin on hydrolysis with hydrochloric acid in
purified water gives Amoxicillin hydrochloride.
• Aqueous layer is separated from organic solvent and is washed
with butyl acetate to remove dissolved methylene chloride.
• By adjusting pH with ammonia solution, Amoxicillin Trihydrate is
precipitated from aqueous layer and is centrifuged, dried,
sifted,mixed and packed
5. The conventional methods for
chemically obtaining (using Dane
salt) amoxicillin typically involve
more than 10 steps, require low-
reaction temperatures (-30°C),
and use toxic solvents like
methylene chloride and silylation
reagents.
It is reported that the production
of one kilogram of amoxicillin
generates up toabout 70 kg of
non-recyclable waste
Enzymatic methods require
far fewer steps, use milder
reaction conditions, and
generate less waste
7. Contract Manufacturing Possibilities
There are Contract
manufacturers offering full
service of sourcing evaluation,
regulation affair support,
custom synthesis/contract
manufacture for outsourcing,
investment solution and suitable
partnership establishment
8. AMOXICILLIN
MARKET
SCENARIO
• The global Amoxicillin Market is forecasted to grow at a rate of 1.5%
from USD 4.50 Billion in 2019 to USD 5.03 Billion in 2027
• North America remains the key revenue generating geographical
segment in Amoxicillin market.
• The geographical segment accounted for USD 1.42 billion in 2018.
• Availability of research funds from public as well as private sources,
availability of state-of-art technologies, presence of key market
players in the region, favorable reimbursements scenarios, rising
focus on precision medicine, and rising awareness about treatments
of infectious diseases, are among the key factors driving the market
growth for Amoxicillin in this region.