pharmaceutical · input

Fluoroquinolone APIs (ciprofloxacin HCl, ofloxacin, moxifloxacin HCl)

Primary antibacterial APIs for ophthalmic infection treatment. India-dominant supply. Ofloxacin ophthalmic on ASHP shortage list since 2022 following Akorn bankruptcy and Sandoz exit.

3

Source countries

4

Companies

1

Goods affected

0

Claims on record

What depends on it

Goods that need this input

1 essential American goods rely on fluoroquinolone apis (ciprofloxacin hcl, ofloxacin, moxifloxacin hcl) somewhere upstream in their supply chain.

Where it comes from

Source countries

Share of global supply, by country.

CountryShare of supply
INIndia55%
CNChina30%
CACanada5%

Who makes it

Supplier companies

4 companies produce fluoroquinolone apis (ciprofloxacin hcl, ofloxacin, moxifloxacin hcl).

Cipla(CIPLA)

HQ IN15% share

Indian generic pharmaceutical company and the world's largest generic inhaler manufacturer by volume. Pioneer of generic salbutamol inhalers in India (1978). Manufactures generic pMDIs at scale. Received FDA final approval for generic Proventil HFA. Critical supplier during COVID-19 when global inhaler demand surged.

Divi's Laboratories Limited

HQ IN12% share

Indian pharmaceutical API manufacturer (NSE: DIVISLAB, HQ Hyderabad; ~₹75B revenue); one of India's largest and most technically sophisticated pharmaceutical API producers, specializing in complex APIs including fluoroquinolones (ciprofloxacin, ofloxacin, levofloxacin), carotenoids (nutraceuticals), and custom synthesis for branded pharmaceutical companies. Divi's Laboratories has never been involved in a major USFDA warning letter or import alert (unusual for an Indian API company of its scale) — maintaining essentially clean regulatory compliance across its multiple Visakhapatnam, Andhra Pradesh production facilities. Divi's produces fluoroquinolone APIs including ciprofloxacin HCl for ophthalmic applications for global generic pharmaceutical customers. Divi's is also one of India's most consistently profitable pharmaceutical companies — its focus on volume API production at high quality has created a near-uninterruptible supply chain position across multiple essential medicines.

Aurobindo Pharma Limited(AUROPHARMA.NS)

HQ IN10% share

Indian generic pharmaceutical company (NSE: AUROPHARMA; HQ Hyderabad, Telangana; ~$3.8B revenue); one of the world's largest generic API and finished dose manufacturers. Aurobindo holds INCB quota approvals for buprenorphine API manufacture in India and exports to regulated markets (US, EU). Aurobindo's controlled substance API operations leverage India's generic pharmaceutical industrial base to serve the post-patent-cliff buprenorphine/naloxone generic market. The company's API and formulation business spans more than 150 drug categories; buprenorphine is produced within its active pharmaceutical ingredients division alongside other Schedule II controlled substances (methadone, tramadol, fentanyl intermediates). Indian buprenorphine API production for export is constrained by INCB country-level quota allocations that limit the aggregate quantity India is authorized to manufacture annually. Aurobindo also produces buprenorphine/naloxone finished dose sublingual films and tablets at its US FDA-approved facilities, sourcing API from its own manufacturing or from other qualified suppliers.

Apotex Inc

HQ CA8% share

Canadian generic pharmaceutical company; one of ~3 remaining US suppliers for ofloxacin ophthalmic solution following Akorn bankruptcy (2023) and Sandoz discontinuation; FDA-approved sterile ophthalmic facility in Toronto.