Relevant Results for
Bromhexine Hydrochloride
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CEP Certificates (EDQM COS List)
SURYA REMEDIES PRIVATE LIMITED Ankleshwar IN
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Product:
Bromhexine hydrochloride
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Type:
Chemical
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Substance Number:
706
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Substance:
SURYA REMEDIES PRIVATE LIMITED Ankleshwar IN
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Status:
Valid
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Issue Date:
2024-10-02
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Country:
India
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Certificate Number:
CEP 2022-414 - Rev 00
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End Date:
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Japan Drug Master Files (JDMF)
FDC LIMITED.
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Product:
Bromhexine hydrochloride
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Latest Registration:
2023-10-12
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Company:
FDC LIMITED.
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Initial Registration:
2023-10-12
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MF Registration Number:
305MF10115
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Registration Category:
APIs
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Registered Address:
142-48,s,v,road,jogeshwari(w),mumbai-400 102 India
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KDMF Registration Details
Aging Life Science Co., Ltd.
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Product:
Bromhexine hydrochloride
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Initial Registration:
2026-05-04
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Registration Number:
20260504-211-J-2191
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MFDS Classification:
Appendix 1
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Applicant:
Aging Life Science Co., Ltd.
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Last Modified:
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Country:
India
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Status:
Active
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Manufacturer:
FDC Limited
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Withdrawal Date:
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Final Annual Reporting Year:
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Manufacturing Facility:
Plot No. 19 & 20/2, MIDC, Roha Industrial Area, Village Dhatav, Roha, Raigad 402116, Maharashtra State, India
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National Drug Code (NDC)
Bidachem S.p.a.
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NDC:
51869-0009
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Nonproprietary Name:
Bromhexine Hydrochloride
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Dosage Form:
POWDER
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Product Type:
BULK INGREDIENT
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Strength:
1000 g/1000g
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Substance:
BROMHEXINE HYDROCHLORIDE
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Start Marketing Date:
2016-04-01
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End Marketing Date:
0000-00-00
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DEA Schedule:
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Certified Through:
2026-12-31
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