Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 2Dr. Reddy's Laboratories
03 1Neuland Laboratories
04 2Alembic Pharmaceuticals Limited
05 1Alkem Laboratories
06 1Aurobindo Pharma Limited
07 1Changzhou Pharmaceutical Factory
08 1Cipla
09 1Glenmark Life Sciences
10 1HEC Pharm
11 1Hainan Poly Pharm
12 1Hetero Drugs
13 1Intas Pharmaceuticals
14 1Jubilant Generics
15 1Lek Pharmaceuticals
16 2Lupin Ltd
17 4MSN Laboratories
18 1Macleods Pharmaceuticals Limited
19 2Quimica Sintetica
20 1Raks Pharma
21 1ScinoPharm Taiwan, Ltd
22 1Sun Pharmaceutical Industries Limited
23 1Unichem Laboratories Limited
24 1Viatris
25 1Zhejiang Huahai Pharmaceutical
26 1Zhejiang Huayi Pharmaceutical Co., Ltd.
27 1Zydus Lifesciences
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-07
Pay. Date : 2016-12-20
DMF Number : 31141
Submission : 2016-11-09
Status :
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 :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32953
Submission : 2018-11-06
Status :
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 :
Type : II
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.
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