LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Faran Shimi Pharmaceutical
03 1Temad Co
04 1EUROAPI
05 1Veranova
06 1Aspen API
07 1Jai Radhe Sales
08 1Rusan Pharma
09 1Deccan Nutraceuticals Pvt. Ltd
10 1HRV Global Life Sciences
11 1Noramco
12 1Parand Darou Pharma
13 1Guangzhou Tosun Pharmaceutical
14 1Hasti Aria Shimi
15 2Mallinckrodt Pharmaceuticals
16 1Micro Orgo Chem
17 1OmnisMed Pharmaceuticals
18 1Resonance Laboratories Pvt. Ltd
19 1SALARAS
20 1Saneca Pharmaceuticals
21 1Siegfried AG
22 2Sun Pharmaceutical Industries Limited
23 1Varion Lifesciences
01 1China
02 1France
03 9India
04 4Iran
05 2Ireland
06 1Italy
07 1Netherlands
08 1Slovakia
09 1Switzerland
10 3U.S.A
11 1United Kingdom
01 8Active
02 1Inactive
03 16Blank
01 8Valid
02 17Blank
01 25Blank
01 1WC-0168
02 1WC-0278
03 23Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-17
Pay. Date : 2013-03-11
DMF Number : 20623
Submission : 2007-06-20
Status : Active
Type : II
Certificate Number : CEP 2009-287 - Rev 03
Issue Date : 2024-03-01
Type : Chemical
Substance Number : 1790
Status : Valid
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2019-05-30
Registration Number : 20190530-209-J-359
Manufacturer Name : Sanofi Winthrop Industrie
Manufacturer Address : Route d'Avignon 30390 Aramon, France
Available Reg Filing : CN |
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-27
Pay. Date : 2012-11-30
DMF Number : 21590
Submission : 2008-04-29
Status : Active
Type : II
Certificate Number : R1-CEP 2008-058 - Rev 00
Issue Date : 2014-09-12
Type : Chemical
Substance Number : 1790
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-16
Pay. Date : 2012-12-20
DMF Number : 15102
Submission : 2000-10-18
Status : Active
Type : II
NDC Package Code : 60870-0395
Start Marketing Date : 1990-01-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2016-053 - Rev 00
Issue Date : 2023-01-13
Type : Chemical
Substance Number : 1790
Status : Valid
Date of Issue : 2021-08-27
Valid Till : 2024-06-10
Written Confirmation Number : WC-0278
Address of the Firm :
NDC Package Code : 70312-0887
Start Marketing Date : 2015-12-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Phamchem Service Co., Ltd.
Registration Date : 2023-10-16
Registration Number : 20210611-209-J-542(2)
Manufacturer Name : Rusan Pharma Ltd.
Manufacturer Address : Plot no. 6406, GIDC ESTATE, ANKLESHWAR, City : ANKLESHWAR - 393 002, Dist : Bharuch, Gujarat State, India
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
NDC Package Code : 45085-0292
Start Marketing Date : 2024-08-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-14
Pay. Date : 2013-12-20
DMF Number : 23325
Submission : 2009-12-01
Status : Active
Type : II
Certificate Number : CEP 2020-291 - Rev 02
Issue Date : 2024-04-23
Type : Chemical
Substance Number : 1790
Status : Valid
NDC Package Code : 51634-1064
Start Marketing Date : 2024-01-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-05
Pay. Date : 2012-11-27
DMF Number : 6265
Submission : 1986-04-11
Status : Active
Type : II
Certificate Number : CEP 2018-218 - Rev 02
Issue Date : 2024-11-20
Type : Chemical
Substance Number : 1790
Status : Valid
NDC Package Code : 0406-1479
Start Marketing Date : 2013-04-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-03-31
Registration Number : 20210331-209-J-569
Manufacturer Name : SpecGx LLC
Manufacturer Address : 3600 North Second Street, St, Louis, Missouri 63147, USA
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21217
Submission : 2007-12-28
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
NDC Package Code : 62756-936
Start Marketing Date : 2024-03-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2024-10-21
Registration Number : 20241021-209-J-1705
Manufacturer Name : Sun Pharmaceutical Industries Ltd.
Manufacturer Address : Plot No. 24/2 & 25, Phase-IV, GIDC Industrial Zone, AT & Post Panoli-394 116, District Bharuch, Gujarat State, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-22
Pay. Date : 2021-12-03
DMF Number : 36560
Submission : 2022-03-17
Status : Active
Type : II
NDC Package Code : 62756-936
Start Marketing Date : 2024-03-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2024-10-21
Registration Number : 20241021-209-J-1705
Manufacturer Name : Sun Pharmaceutical Industries Ltd.
Manufacturer Address : Plot No. 24/2 & 25, Phase-IV, GIDC Industrial Zone, AT & Post Panoli-394 116, District Bharuch, Gujarat State, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-16
Pay. Date : 2013-01-28
DMF Number : 23214
Submission : 2009-10-21
Status : Active
Type : II
Certificate Number : R1-CEP 2009-352 - Rev 03
Issue Date : 2023-02-15
Type : Chemical
Substance Number : 1790
Status : Valid
NDC Package Code : 0792-3941
Start Marketing Date : 2024-11-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : CTC Bio Co., Ltd.
Registration Date : 2020-09-23
Registration Number : 20200923-209-J-729
Manufacturer Name : Siegfried PharmaChemikalien Minden GmbH
Manufacturer Address : Karlstraße 15-39, 42-44, 32423 Minden, Germany
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21820
Submission : 2008-07-17
Status : Inactive
Type : II
NDC Package Code : 0406-1479
Start Marketing Date : 2013-04-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-03-31
Registration Number : 20210331-209-J-569
Manufacturer Name : SpecGx LLC
Manufacturer Address : 3600 North Second Street, St, Louis, Missouri 63147, USA
Certificate Number : R1-CEP 2006-117 - Rev 02
Issue Date : 2017-05-05
Type : Chemical
Substance Number : 1790
Status : Valid
NDC Package Code : 69641-0001
Start Marketing Date : 2015-02-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
NDC Package Code : 16447-0690
Start Marketing Date : 2023-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2017-313 - Rev 02
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 1790
Status : Valid
NDC Package Code : 82105-004
Start Marketing Date : 2023-08-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Naltrexone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naltrexone Hydrochloride, including repackagers and relabelers. The FDA regulates Naltrexone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naltrexone Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Naltrexone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naltrexone Hydrochloride supplier is an individual or a company that provides Naltrexone Hydrochloride active pharmaceutical ingredient (API) or Naltrexone Hydrochloride finished formulations upon request. The Naltrexone Hydrochloride suppliers may include Naltrexone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Naltrexone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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