01 1ZENARA
02 3DR REDDYS
03 2AUCTA
04 3ANNORA PHARMA
05 1AUROBINDO PHARMA
06 3BIOMARIN PHARM
07 3ENDO OPERATIONS
01 10POWDER;ORAL
02 6TABLET;ORAL
01 16RX
01 3KUVAN
02 11SAPROPTERIN DIHYDROCHLORIDE
03 2ZELVYSIA
01 13No
02 3Yes
RLD : No
TE Code : AB
Brand Name : SAPROPTERIN DIHYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2025-06-11
Application Number : 218797
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AB
Brand Name : SAPROPTERIN DIHYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2021-06-15
Application Number : 207685
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Aucta is a global brand that creates better products from proven molecules.
RLD : No
TE Code : AB
Brand Name : ZELVYSIA
Dosage Form : POWDER;ORAL
Dosage Strength : 100MG/PACKET
Approval Date : 2025-04-29
Application Number : 218645
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AB
Brand Name : SAPROPTERIN DIHYDROCHLORIDE
Dosage Form : POWDER;ORAL
Dosage Strength : 100MG/PACKET
Approval Date : 2021-03-30
Application Number : 209452
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AB
Brand Name : SAPROPTERIN DIHYDROCHLORIDE
Dosage Form : POWDER;ORAL
Dosage Strength : 500MG/PACKET
Approval Date : 2022-05-13
Application Number : 215798
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Aucta is a global brand that creates better products from proven molecules.
RLD : No
TE Code : AB
Brand Name : ZELVYSIA
Dosage Form : POWDER;ORAL
Dosage Strength : 500MG/PACKET
Approval Date : 2025-04-29
Application Number : 218645
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : KUVAN
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2007-12-13
Application Number : 22181
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : KUVAN
Dosage Form : POWDER;ORAL
Dosage Strength : 100MG/PACKET
Approval Date : 2013-12-19
Application Number : 205065
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : KUVAN
Dosage Form : POWDER;ORAL
Dosage Strength : 500MG/PACKET
Approval Date : 2015-10-27
Application Number : 205065
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code : AB
Brand Name : SAPROPTERIN DIHYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2019-05-10
Application Number : 207200
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
