Producer
Intas Pharmaceuticals / Accord Healthcare
Intas Pharmaceuticals (Ahmedabad Gujarat India; privately held; founded 1976 by Hasmukh Chudgar; ~$2.4B revenue est. 2022) is the world's largest manufacturer of cisplatin and carboplatin APIs and one of India's largest private pharmaceutical companies. Intas operates its international generic injectable business under the brand Accord Healthcare (UK-registered subsidiary). Intas's Ahmedabad/Sanand API manufacturing complex in Gujarat was the single most important source of cisplatin API for the US market, supplying an estimated 50-60% of US cisplatin imports from its Gujarat facilities. In November 2022, FDA investigators conducting a pre-approval inspection at Intas's Ahmedabad manufacturing facility (FEI 3003889748) discovered hundreds of trash bags filled with shredded quality-control documents — evidence of deliberate document destruction intended to conceal data integrity violations. FDA issued a Form 483 with 10 observations. The FDA subsequently issued a Warning Letter in December 2022. Intas voluntarily ceased API production at the facility. The resulting API supply gap triggered the worst US oncology drug shortage in a decade, beginning in February 2023 for cisplatin and April 2023 for carboplatin. The Intas-Accord shortage became the central case study for pharmaceutical supply chain concentration risk.
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Inputs supplied
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Goods downstream
3
Facilities
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Stories
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4 inputs Intas Pharmaceuticals / Accord Healthcare supplies
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Where they make it
3 facilities
Intas Pharmaceuticals Ahmedabad API Manufacturing Complex →
INGujarat · manufacturing
Intas Pharmaceuticals' primary API manufacturing complex in Ahmedabad, Gujarat (including the Sanand industrial estate satellite facility, ~30 km southwest of Ahmedabad city center). FDA FEI 3003889748. This facility was the world's single largest cisplatin API production site, supplying an estimated 50-60% of US cisplatin requirements. FDA investigators visited in November 2022 and discovered hundreds of trash bags of shredded quality-control documentation — evidence of systematic data integrity violations. FDA issued 10 observations in the Form 483 and a Warning Letter in December 2022. Intas voluntarily suspended API production. The shutdown triggered the US cisplatin shortage that began February 2023 and the carboplatin shortage that began April 2023. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-667094-12222022
Intas Pharmaceuticals Ahmedabad Formulations (Accord Healthcare) →
INGujarat · manufacturing
Intas's Ahmedabad finished-dose (formulation) manufacturing facility, distinct from the API plant; produces injectable vials of cisplatin and carboplatin under the Accord Healthcare brand for UK/EU markets and under Intas branding for emerging market export. This facility takes cisplatin/carboplatin API (from the adjacent API plant or other sources) and fills, finishes, and packages the injectable vials for hospital use. The Accord Healthcare brand (UK registered) is Intas's vehicle for selling generic oncology injectables into European and export markets. Source: https://www.accordhealthcare.com/oncology
Intas Sanand Plant (Accord Healthcare) →
INGujarat · manufacturing
Supplied ~50% of US cisplatin; FDA 2022 inspection found hundreds of trash bags of shredded quality-control documents; triggered 2023 US cisplatin and carboplatin shortages.
What else they do
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Global Generics (Accord Healthcare)
47%India Formulations (Branded Generics)
31%API and Contract Manufacturing
14%Biologics and Biosimilars
8%
Intelligence
What's known
Sourced claims about this company's role in supply chains, chokepoints, concentration, incidents, dual-use connections.
Incident2022
Intas Pharmaceuticals is India's largest privately-held pharmaceutical company and was, until the 2022 FDA enforcement action, arguably the world's most important cisplatin and carboplatin supplier. The FDA Warning Letter disclosed that when investigators arrived at the Ahmedabad facility in November 2022, they observed employees actively destroying documents — shredding quality records, discarding laboratory notebooks, and removing analytical data. The scale of document destruction (hundreds of trash bags) indicated systematic, pre-planned evidence removal rather than routine document disposal. This represented not a manufacturing quality failure but a deliberate fraud against FDA oversight. Under US law, submitting false information to FDA in a Drug Master File (DMF) or ANDA is a federal felony. The Indian subsidiary and potentially individual employees faced potential criminal referral. The incident occurred against a backdrop of FDA's Project Raven (2022-2023 initiative to increase India and China API inspection frequency and data integrity enforcement) — Intas was among the most prominent enforcement outcomes. What made the Intas case distinctive was the scale: destroying hundreds of bags of records at the moment of FDA arrival was so brazen that it became the defining symbol of data integrity failures in Indian pharmaceutical API manufacturing.
U.S. Food and Drug Administration ↗Did you know2022
Intas Pharmaceuticals — the Indian generics company responsible for the worst US oncology drug shortage in a decade when FDA found shredded QC documents at its Ahmedabad facility in November 2022 — also manufactures buprenorphine API, the active ingredient in Suboxone and Subutex used to treat opioid use disorder. A single company's regulatory failure simultaneously threatened both cancer chemotherapy supply (cisplatin, carboplatin) and opioid addiction treatment supply (buprenorphine). The Intas case demonstrates how Indian API concentration creates multi-therapeutic exposure from single facility disruptions.
U.S. Food & Drug Administration ↗Capacity2023
At its peak before the 2022 FDA action, Intas's Ahmedabad facility (FEI 3003889748) produced an estimated 50-60% of US cisplatin imports and 30-40% of US carboplatin imports. After the voluntary production halt triggered by the December 2022 Warning Letter, the American Society of Health-System Pharmacists (ASHP) declared a national shortage of cisplatin in February 2023 and carboplatin in April 2023. Oncology centers across the US were forced to ration chemotherapy, delay treatment initiation, and switch patients to alternative regimens — in some cases to less effective protocols. The shortage lasted more than 6 months before alternative suppliers (Pfizer/Hospira, Fresenius Kabi, Teva) could ramp production.
American Society of Health-System Pharmacists ↗Origin2023
Intas Pharmaceuticals is a private family-controlled company — founded in 1976 by Hasmukh Chudgar in Ahmedabad, still controlled by the Chudgar family — that grew from a domestic Indian branded generics business into the world's largest manufacturer of platinum-based oncology APIs. The company entered the US and EU markets through its UK-registered subsidiary Accord Healthcare, which became a dominant supplier of oncology injectables by undercutting branded manufacturers with low-cost Indian API. Intas had no public market accountability (no listed shares) and limited external financial oversight when the 2022 FDA inspection uncovered document destruction at its primary facility.
Intas Pharmaceuticals ↗