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SAPROPTERIN DIHYDROCHLORIDE

ANDA

SAPROPTERIN DIHYDROCHLORIDE | A219511 | MICRO LABS LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: KUVAN(TE code: AB)

API Supply Chain9 active DMFs

8 active API suppliers hold Drug Master Files for this ingredient.

DIPHARMA SASAPROPTERIN DIHYDROCHLORIDE

DMF 266822012

ASYMCHEM LABORATORIES TIANJIN CO LTDSAPROPTERIN

DMF 284162014

INNOPHARMAX INCSAPROPTERIN DIHYDROCHLORIDE

DMF 335532019

HONOUR LAB LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 339282019

SOLARA ACTIVE PHARMA SCIENCES LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 341852019

DIPHARMA SASAPROPTERIN DIHYDROCHLORIDE (NEW PROCESS)

DMF 349262020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 361472021

MAITHRI DRUGS PRIVATE LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 410772024

CHONGQING MIDECO PHARMACEUTICAL CO LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 421462025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — 100MG/PACKET

0 patents0 exclusivities▴

POWDER;ORAL | Approved: Jan 8, 2026

No patent or exclusivity listings for this strength.

#002 — 500MG/PACKET

0 patents0 exclusivities▾

POWDER;ORAL | Approved: Jan 8, 2026