Cipla logo

Cipla

India (Mumbai) • Manufacturer

Cipla is a peptide manufacturer based in India (Mumbai). Direct manufacturer. Founded 1935. Holds US DMFs for difelikefalin, icatibant, terlipressin API.

FDA warning letter
The U.S. FDA sent Cipla a warning letter dated November 17, 2023 (Pithampur, Madhya Pradesh finished-dose facility, not a peptide API site). Read the letter on fda.gov. A warning letter is not a court ruling, and companies can respond to it; check fda.gov for any close-out letter.
FDA warning letter
The U.S. FDA sent Cipla a warning letter dated February 12, 2020 (Goa finished-dose facility, re-inspected and classed VAI in June 2024). Read the letter on fda.gov. A warning letter is not a court ruling, and companies can respond to it; check fda.gov for any close-out letter.
ConfidenceMedium
Business TypeManufacturer
ModelManufacturer
RegionAsia
Founded1935
Verification status based on publicly available information and supplier-provided materials.

Listing reviewed October 2026.

Is this your company? Claim this listing to update your info and get a verified badge.Claim This Listing

Mumbai-based pharmaceutical group, founded in 1935, making generic medicines and APIs. Holds active US Drug Master Files for difelikefalin, icatibant and terlipressin API and markets icatibant injection in the US. Its Kurkumbh API site was classed VAI at its 2024 FDA inspection. The FDA warning letters below were issued to finished-dose sites, not a peptide API site.

Directory assessment: Cipla is listed as a manufacturer in the peptide supply chain, serving Asia markets from India (Mumbai). As a direct manufacturer, this supplier controls its own production process from synthesis through purification and quality control release testing. This profile lists 3 sources for reference. This supplier has a medium confidence score — verification signals are present, but the listing is newer or less documented; perform standard due diligence before engaging.

Products (2)
peptide APIsgeneric medicines
Capabilities
US Drug Master Files
  • Difelikefalin: DMF 37712 (Type II, active), submitted 2023-01-25
  • Icatibant: DMF 32318 (Type II, active), submitted 2018-01-08
  • Terlipressin: DMF 43499 (Type II, active), submitted 2026-04-15

DMF numbers from the FDA quarterly DMF list. A filed DMF is not FDA approval; its contents are confidential. Reviewed 2026-10-23.