European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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01 1Polpharma
02 2Dr. Reddy's Laboratories
03 1Neuland Laboratories
04 2Lupin Manufacturing Solutions
05 2Alembic Pharmaceuticals Limited
06 1Alivus Life Sciences
07 1Alkem Laboratories
08 1Aurobindo Pharma Limited
09 1Changzhou Pharmaceutical Factory
10 1Cipla
11 1HEC Pharm
12 1Hainan Poly Pharm
13 1Hetero Drugs
14 1Intas Pharmaceuticals
15 1Jubilant Generics
16 1Lek Pharmaceuticals
17 4MSN Laboratories
18 1Macleods Pharmaceuticals Limited
19 1Megafine Pharma (P) Limited
20 2Quimica Sintetica
21 1Raks Pharma
22 1ScinoPharm Taiwan Ltd
23 1Sun Pharmaceutical Industries Limited
24 1Unichem Laboratories Limited
25 1Viatris
26 1Zhejiang Huahai Pharmaceutical
27 1Zhejiang Huayi Pharmaceutical Co., Ltd.
28 1Zydus Lifesciences
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01 22APREMILAST
02 2APREMILAST (AMORPHOUS)
03 1APREMILAST (CRYSTALLINE)
04 1APREMILAST (FORM B)
05 1APREMILAST (FORM M)
06 2APREMILAST (FORM-B)
07 1APREMILAST (FORM-M)
08 1APREMILAST (NON-STERILE DRUG SUBSTANCE)
09 1APREMILAST (PROCESS II)
10 1APREMILAST NON-STERILE BULK DRUG SUBSTANCE
11 1APREMILAST [AMORPHOUS]
12 1APREMILAST [ROUTE CODE LI]
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01 5China
02 24India
03 1Poland
04 1Slovenia
05 2Spain
06 1Taiwan
07 1U.S.A
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01 34Active
02 1Inactive
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01 25Complete
02 10Blank
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-07
Pay. Date : 2016-12-20
DMF Number : 31141
Submission : 2016-11-09
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-05
Pay. Date : 2016-11-15
DMF Number : 30732
Submission : 2016-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32953
Submission : 2018-11-06
Status : Active
Type : II
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-24
Pay. Date : 2016-04-04
DMF Number : 30248
Submission : 2016-04-06
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-02
Pay. Date : 2017-08-29
DMF Number : 31356
Submission : 2017-06-02
Status : Active
Type : II
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-09
Pay. Date : 2017-05-25
DMF Number : 31266
Submission : 2017-03-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-20
Pay. Date : 2017-10-10
DMF Number : 31159
Submission : 2016-12-23
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-11-17
Pay. Date : 2017-10-10
DMF Number : 30866
Submission : 2016-08-31
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-02-03
Pay. Date : 2016-09-29
DMF Number : 30332
Submission : 2016-03-29
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2016-12-27
DMF Number : 31180
Submission : 2016-12-29
Status : Active
Type : II

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PharmaCompass offers a list of Apremilast API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Apremilast manufacturer or Apremilast supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Apremilast manufacturer or Apremilast supplier.
PharmaCompass also assists you with knowing the Apremilast API Price utilized in the formulation of products. Apremilast API Price is not always fixed or binding as the Apremilast Price is obtained through a variety of data sources. The Apremilast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Apremilast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apremilast, including repackagers and relabelers. The FDA regulates Apremilast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apremilast 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 Apremilast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apremilast supplier is an individual or a company that provides Apremilast active pharmaceutical ingredient (API) or Apremilast finished formulations upon request. The Apremilast suppliers may include Apremilast API manufacturers, exporters, distributors and traders.
click here to find a list of Apremilast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Apremilast DMF (Drug Master File) is a document detailing the whole manufacturing process of Apremilast active pharmaceutical ingredient (API) in detail. Different forms of Apremilast DMFs exist exist since differing nations have different regulations, such as Apremilast USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apremilast DMF submitted to regulatory agencies in the US is known as a USDMF. Apremilast USDMF includes data on Apremilast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apremilast USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Apremilast suppliers with USDMF on PharmaCompass.
We have 27 companies offering Apremilast
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