LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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01 1LGM Pharma
02 1Jai Radhe Sales
03 1Octavius Pharma Pvt. Ltd
04 1Tenatra Exports
05 1TAPI Technology & API Services
06 1Amsal Chem Private Ltd.
07 3AstraZeneca
08 1DEAFARMA
09 1Darou Pakhsh Pharma Chem
10 1Emcure Pharmaceuticals
11 1Erregierre SpA
12 1HELM Portugal
13 1Harman Finochem
14 11Ipca Laboratories
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18 1Nishchem International Pvt. Ltd
19 1Osmopharm
20 1Pcca
21 1Recordati
22 1Recordati Rare Diseases
23 1SIMS Srl
24 1SINTENOVO, S.A. DE C.V.
25 1Shanghai Ziyuan Pharmaceutical
26 1Sneha Medicare Pvt Ltd
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28 1Syn-Tech Chem. & Pharm
29 1Teva Pharmaceutical Industries
30 1Viatris
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01 2China
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01 6Active
02 20Inactive
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01 6Valid
02 1Withdrawn by Holder
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01 1218MF10439
02 1222MF10107
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01 1WC-0076
02 1WC-0084
03 1WC-0090
04 1WC-0091
05 1WC-0103
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01 120050831-34-B-86-01
02 120050831-34-B-88-03
03 120050831-34-B-91-04
04 120050831-34-B-91-04(1)
05 120050831-34-B-91-04(10)
06 120050831-34-B-91-04(12)
07 120050831-34-B-91-04(2)
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10 120050831-34-B-91-04(5)
11 120050831-34-B-91-04(6)
12 120050831-34-B-91-04(7)
13 120050831-34-B-91-04(8)
14 120110414-125-H-59-01
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01 138779-0262
02 148589-0007
03 151927-0208
04 157451-1115
05 161294-9994
06 165841-101
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 2004-030 - Rev 09
Issue Date : 2026-03-30
Type : Chemical
Substance Number : 703
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-11
Pay. Date : 2012-11-13
DMF Number : 6213
Submission : 1986-03-05
Status : Active
Type : II
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-34-B-86-01
Manufacturer Name : Teva Pharmaceutical Fine Chemicals srl
Manufacturer Address : Via E. Fermi 20/26, 20019 Settimo Milanese (MI)

GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-14
Pay. Date : 2016-03-21
DMF Number : 24024
Submission : 2010-08-10
Status : Active
Type : II
Certificate Number : R1-CEP 2016-226 - Rev 00
Issue Date : 2023-05-02
Type : Chemical
Substance Number : 703
Status : Valid
Date of Issue : 2025-08-26
Valid Till : 2028-08-25
Written Confirmation Number : WC-0076
Address of the Firm :
NDC Package Code : 48589-0007
Start Marketing Date : 2016-09-19
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6979
Submission : 1987-05-05
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21617
Submission : 2008-05-12
Status : Inactive
Type : II
Registration Number : 222MF10107
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2010-03-23
Latest Date of Registration :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20268
Submission : 2007-02-13
Status : Inactive
Type : II

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A Noten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Noten, including repackagers and relabelers. The FDA regulates Noten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Noten API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Noten supplier is an individual or a company that provides Noten active pharmaceutical ingredient (API) or Noten finished formulations upon request. The Noten suppliers may include Noten API manufacturers, exporters, distributors and traders.
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