Parawada, Anakapalli – 531019. Andhra Pradesh. +91 – 8924 – 236232 info@admironls.in

INTERMEDIATES

Accreditations

<strong>Drug license (32/VP/AP/2013/B/R)</strong> issued by DCA, AP, Valid up to 21-11-2023 (Applied and awaiting for audit and approval)

Drug license (32/VP/AP/2013/B/R) issued by DCA, AP, Valid up to 21-11-2023 (Applied and awaiting for audit and approval)

<strong>GMP & GLP certificate</strong> issued by DCA, AP, valid up to 27-06-2024

GMP & GLP certificate issued by DCA, AP, valid up to 27-06-2024

<strong>WHO GMP certificate</strong> issued by CDSCO, India, valid up to 25-05-2021 (Applied and awaiting for audit and approval)

WHO GMP certificate issued by CDSCO, India, valid up to 25-05-2021 (Applied and awaiting for audit and approval)

Faced and qualified the <strong>USFDA</strong> Audit for Clorsulon Intermediate on September 10-14th 2018.

Faced and qualified the USFDA Audit for Clorsulon Intermediate on September 10-14th 2018.

List of Intermediates

Acrivastine intermediates

Brivaracetam Intermediates

Cilastatin Intermediates

Clobazam Intermediates

Clorsulon Intermediates

Dapagliflozin Intermediates

Empagliflozin Intermediates

Etoricoxib
Intermediates

Lufenuron
Intermediates

Metopimazine Intermediates

Nefopam Hydrochloride Intermediates

Nitroscanate Intermediates

Nitroxynil
Intermediates

Oxcarbazepine Intermediates

Praziquantel Intermediates

Sitagliptin
Intermediates

Telmisartan Intermediates

Intermediates / Products

Filled for Regulatory markets

Drug substance name Country of submission DMF number Status
STA (INT) Germany, France, Spain,
Australia, Korea		 4727, 2022-030, AA/0080/22,
D22-5797412, 20230019195 		Under review
Etoricoxib (API) Sweden, United kingdom,
Spain, Germany, Ireland, Malta		 2019/006, MFD-22481-00230,
AA/0135/18, 4185, 47010000 		Under review
Acrivastine (INT) UK MFD-22481-1-09451-0001 Approved
Finland -- Approved
Denmark 2215-2844 Under review
Clobazam (INT) EDQM R0-CEP 2019-168-Rev 01 Approved
USFDA 032059 Under review
Telmisartan (API) EDQM R0-CEP 2020-388-Rev 01 Approved
Moxifloxacin (API) EDQM CEP 2022-023 Under review
Metopimazine (INT) France 2020-074 Approved
Celecoxib (API) EDQM R0-CEP 2022-345-Rev 00 Approved
Ethambutol Hydrochloride
(EHB) 		EDQM CEP-2023-224-Rev 00 Approved
10-Methoxyimino stilbene
(OCR-S1) 		USFDA 038794 Under review
Nefopam Hydrochloride
(NEF-V) 		Ireland DMF47010001 Approved
UK MFD-22481-2-08681 Approved
Estonia ----- Approved
Cyprus ----- Approved
Malta ----- Approved
Netherlands ----- Approved
France 2022-002 Approved
Australia D22-56199962 Under review
New Zeeland TT60-997-13-5 Under review
Russia ----- Approved

List of Intermediates

Nefopam Hydrochloride Stage-V (NEF-V)

TEI-2 Intermediate

Clobazam Stage-I (CLO1)

Clobazam Stage-II (CLO2)

Clobazam Stage-III (CLO3)

3-Pyrollidino]-4-(tolyl)-propan-1-one hydrochloride (ACR-S1)

Acrivastine Stage-1(ACR1)

Clorsulon-IV Intermediates

Praziquantel Intermediates

Nitroscanate stage-IV crude Intermediates

Nitroxynil
Crude

MTO1 &
MTO2

ECB-I & ECB-II

Sitagliptin-II (STA-2)

Sitagliptin-IV (STA-4)

Sitagliptin-V (STA-5)

5-Hydroxy-4-propyturan-2(5H) one (BRV-S1)

Brivaracetam (BRV1)

Brivaracetam (BRV2)

Brivaracetam (BRV3)

OCR-0

LFN-II

EMP-8

DAP2

DAP3

DAP6

CIL-I & CIL-II