pharmaceutical · input
Vitamin A acid; standard of care for acne vulgaris (Retin-A) and actinic keratosis; manufactured in India (Dr. Reddy's, Sun Pharma, IPCA); experienced acute US shortage 2022-23 due to Indian manufacturing quality holds; no direct substitute
3
Source countries
4
Companies
1
Goods affected
0
Claims on record
What depends on it
1 essential American goods rely on tretinoin (all-trans retinoic acid) api somewhere upstream in their supply chain.
Who makes it
4 companies produce tretinoin (all-trans retinoic acid) api.
Major Indian pharmaceutical company (NYSE: RDY); one of India's largest generic drug manufacturers. Major tretinoin API producer; also produces wide range of generic APIs and formulations for US, EU, and global markets. Second-largest Indian pharma company by revenue. API manufacturing in Hyderabad, Vizag (Visakhapatnam), and other sites.
Indian API and formulation manufacturer; one of the key tretinoin API producers. Major supplier of generic API to US, EU, and global markets. BSE/NSE listed. Ratlam (Madhya Pradesh) and other facilities. IPCA was subject to FDA import alert in 2015 affecting US supply of multiple APIs -- demonstrating how a single enforcement action against one Indian API manufacturer can create shortage of multiple drugs simultaneously.
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.
