§1What this business is

Chloramphenicol is reacted with palmitoyl chloride in the presence of pyridine in steam-jacketed stainless-steel reactors. The crude ester is poured into dilute hydrochloric acid, filtered, washed with toluene and dimethyl formamide, then dried, recrystallised and pulverised. It must meet the Indian Pharmacopoeia standard. Pharma companies use it to make chloramphenicol syrups because it lacks the bitter taste of the parent drug.

Capacity: 8 tonnes a year worth ₹92.00 L at ₹1,150 a kg; two shifts of 8 hours.

§2Is it right for you?

Who it is for

A pharma chemist with bulk-drug experience and contacts among formulation companies.

Who it is not for

Anyone without pharmacy or chemistry qualifications — the licence needs qualified technical staff.

Advantages

  • A specific product with steady use in syrups
  • The report notes export of chloramphenicol was rising
  • Equipment can be made in India

Drawbacks

  • Needs a drug manufacturing licence and GMP — slow and strict
  • Uses solvents and pyridine — fire and health hazards
  • Profit depends on the price of chloramphenicol, the main input

Skills you need

  • Organic synthesis and recrystallisation
  • Pharmacopoeia testing (spectrophotometer, TLC)
  • GMP documentation

Why difficulty 5/5: A licensed bulk drug with hazardous solvents and strict quality rules.

§3Market

Who buys

  • Pharma formulation companies making antibiotic syrups
  • Bulk-drug traders and exporters

How it sells

  • Direct supply with a certificate of analysis
  • Sales representatives (two are budgeted in the report)

Good to know

  • The report says chloramphenicol is made in both small and large units and its export showed a rising trend.
  • About 174 mg of the palmitate equals 100 mg of chloramphenicol, as the report notes.

§4Raw material & machinery

ItemQtyCost
Stainless-steel reactor, 500 litres, with reflux condenser and steam jacket2₹3,00,000
Steam-heated tray drier with vacuum drying1₹1,50,000
Demineralised water plant1₹50,000
Storage tanks for toluene, dimethyl formamide and hydrochloric acid2₹2,00,000
Boiler1₹1,00,000
Filtration unit1₹1,00,000
Pulveriser1₹50,000
Laboratory equipment (spectrophotometer, TLC, centrifuge, oven, glassware)lot₹2,50,000

From: DC-MSME project profile — Chloramphenicol Palmitate (2003)

  • Chloramphenicol405 kg a month at ₹1,100 a kg in the report
  • Palmitoyl chloride324 kg a month at ₹65 a kg
  • Pyridine, toluene, dimethyl formamide₹30,000 a month (lump sum)
  • Packing material₹9,500 a month

From: DC-MSME project profile — Chloramphenicol Palmitate (2003)

§5Licences & registration

  1. Udyam registration
  2. GST registration
  3. Drug manufacturing licence from the State Drugs Controller under the Drugs and Cosmetics Act
  4. GMP compliance as required by the licensing authority
  5. State Pollution Control Board consent to establish and operate
  6. Boiler registration under the Boilers Act
  7. Factory licence if your worker count crosses the Factories Act limit

We can do this registration for you

§6Schemes & subsidies

PMEGP fits (₹38.05 L, under the ₹50 L manufacturing limit); CGTMSE for a loan without collateral; Stand-Up India for SC/ST and women founders.

§7Money

How the investment is worked out: Land and building ₹6.50 L + machinery and equipment ₹13.65 L (incl. erection, furniture, pre-operative) + working capital for 3 months ₹17.90 L = ₹38.05 L.

Working capital: Working capital for 3 months ₹17.90 L; chloramphenicol alone costs ₹4.46 L a month.

Prices from 2003 — machinery, material and selling prices will be much higher now.

How to prepare a loan file

§8Export potential

Confirm the HS code in the DGFT ITC(HS) lookup before you export

2941.40Chloramphenicol and its derivatives; salts thereof

Export council / board: Pharmexcil (Pharmaceuticals Export Promotion Council of India)

  • Confirm the 8-digit ITC(HS) line with DGFT or your customs broker before shipping.
  • Most importing countries also ask for GMP certificates and product registration.
  • You need an Import Export Code (IEC) from DGFT before the first shipment.

§9Risks — where people fail

  • Batch failure against Pharmacopoeia limits
  • Solvent fire or exposure
  • Licence suspension after an inspection

§1030 / 60 / 90-day plan

A general plan that applies to any business. A plan for this business will be added after research.

  1. Days 1–30: Visit a working chloramphenicol palmitate (bulk drug) unit, ask 10 buyers about price and quantity, and get quotations from 3 suppliers.
  2. Days 31–60: Udyam and the licences you need (Udyam registration, GST registration), a project report (DPR), and the scheme or loan file.
  3. Days 61–90: Space and machines, trial production, and first deliveries to 10 customers.

§11Who to connect with

Not verified yet

Associations, clusters and training institutes — the directory is being built. Connect

§12Watch

There is no episode on this business yet. Shows are coming soon on the Podcast page.

Want to start Chloramphenicol Palmitate (Bulk Drug)?

DPR, loan file or registration — ask us on WhatsApp.

Get a DPR / loan file made

Sources

  1. DC-MSME project profile — Chloramphenicol Palmitate (2003)

Data review: 6 October 2026. Spotted a mistake? Report it. For information only — not legal or financial advice.