Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Alembic Pharmaceuticals Limited
03 1Amphastar Pharmaceuticals
04 1Auro Peptides Limited
05 1Chengdu Shengnuo Biopharm
06 2Hybio Pharmaceutical
07 1MSN Laboratories
08 1ScinoPharm Taiwan, Ltd
09 1Sun Pharmaceutical Industries Limited
10 1Blank
01 1PARATHYROID HORMONE (1-34) HUMAN
02 4TERIPARATIDE
03 4TERIPARATIDE USP
04 1TERIPARATIDE, NON STERILE BULK DRUG SUBSTANCE
05 1TERIPARATIDE, NON-STERILE BULK DRUG SUBSTANCE
01 3China
02 4India
03 1Switzerland
04 1Taiwan
05 1U.S.A
06 1Blank
01 11Active
01 7Complete
02 4Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8509
Submission : 1990-04-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-09-29
DMF Number : 38923
Submission : 2023-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-09
Pay. Date : 2019-05-17
DMF Number : 33857
Submission : 2019-05-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-19
Pay. Date : 2018-08-13
DMF Number : 33079
Submission : 2018-08-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-22
Pay. Date : 2019-06-17
DMF Number : 32144
Submission : 2019-02-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-21
Pay. Date : 2021-12-22
DMF Number : 36502
Submission : 2021-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34388
Submission : 2019-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34713
Submission : 2020-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-24
Pay. Date : 2019-05-16
DMF Number : 33210
Submission : 2019-01-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-03
Pay. Date : 2021-02-05
DMF Number : 35583
Submission : 2021-02-22
Status : Active
Type : II
A Teriparatide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teriparatide, including repackagers and relabelers. The FDA regulates Teriparatide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teriparatide 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 Teriparatide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Teriparatide supplier is an individual or a company that provides Teriparatide active pharmaceutical ingredient (API) or Teriparatide finished formulations upon request. The Teriparatide suppliers may include Teriparatide API manufacturers, exporters, distributors and traders.
click here to find a list of Teriparatide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Teriparatide DMF (Drug Master File) is a document detailing the whole manufacturing process of Teriparatide active pharmaceutical ingredient (API) in detail. Different forms of Teriparatide DMFs exist exist since differing nations have different regulations, such as Teriparatide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Teriparatide DMF submitted to regulatory agencies in the US is known as a USDMF. Teriparatide USDMF includes data on Teriparatide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Teriparatide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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