pharmaceutical · input

Tacrolimus API (FK506)

Macrolide immunosuppressant produced by Streptomyces tsukubaensis fermentation; active in Protopic® ointment for atopic dermatitis; FDA black-box warning (theoretical cancer risk) has suppressed use despite guideline support; Astellas holds innovator patents; generic tacrolimus API from India

3

Source countries

5

Companies

1

Goods affected

0

Claims on record

What depends on it

Goods that need this input

1 essential American goods rely on tacrolimus api (fk506) somewhere upstream in their supply chain.

Where it comes from

Source countries

Share of global supply, by country.

CountryShare of supply
INIndia55%
CNChina25%
JPJapan14%

Who makes it

Supplier companies

5 companies produce tacrolimus api (fk506).

Concord Biotech Limited(543952.BO)

HQ IN22% share

Indian fermentation-based API specialist; leading global maker of immunosuppressant APIs (tacrolimus, sirolimus, mycophenolate) and other fermentation products.

Sun Pharmaceutical Industries(SUNPHARMA.NS)

HQ IN10% share

Astellas Pharma Inc.(4503.T)

HQ JP

Japanese pharmaceutical company; originator of tacrolimus (FK506 / Protopic®) for atopic dermatitis and Prograf® for organ transplant; tacrolimus was discovered from soil bacterium Streptomyces tsukubaensis sampled near Mount Tsukuba, Japan in 1984; the dermatology formulation opened a new non-steroidal treatment class.

Biocon Biologics(BIOCON.NS)

HQ IN

Indian biotechnology and pharmaceutical company (NSE: BIOCON; Biocon Biologics listed separately; HQ Bangalore; ~₹150B revenue for Biocon group); Biocon is India's largest biopharmaceutical company and a major producer of complex small molecules and biologics including cyclosporine A API and immunosuppressants. Biocon Limited was founded in 1978 by Kiran Mazumdar-Shaw — one of India's most prominent female entrepreneurs — as an enzyme fermentation company, starting in a garage with ₹10,000 in capital. Today Biocon is a ~$3B revenue pharmaceutical company producing insulin biosimilars, cancer biologics, and complex small molecule APIs including cyclosporine A. The same Biocon that produces the cyclosporine A API for generic dry eye drops also produces trastuzumab biosimilar (Herceptin equivalent for breast cancer) and insulin analogs for diabetes — one Indian startup from 1978 spanning oncology, endocrinology, and ophthalmology API supply chains.

Dr. Reddy's Laboratories

HQ IN

Indian multinational pharmaceutical company (NSE: DRREDDY; HQ Hyderabad) with significant irinotecan API and finished dose manufacturing. Dr. Reddy's manufactures irinotecan hydrochloride injection for the U.S. and European generic markets — one of the leading generic irinotecan suppliers approved by FDA and EMA. The company converts camptothecin (procured primarily from Chinese botanical extraction sources) into irinotecan API via semi-synthesis at its Hyderabad API facilities. Dr. Reddy's broader oncology generics franchise includes paclitaxel, docetaxel, and topotecan, making it one of the few Indian companies with a full camptothecin-class API portfolio. Supply of irinotecan to the U.S. critical care oncology market is a significant part of the company's FDA-regulated generic pharmaceutical business.