Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1ChemWerth Inc
03 1LGM Pharma
04 1Rochem International Inc
05 1HRV Global Life Sciences
06 1Omgene Life Sciences Pvt. Ltd
07 1Beijing Mesochem Technology
08 1Alembic Pharmaceuticals Limited
09 1Amphastar Pharmaceuticals
10 1Auro Peptides Limited
11 1Aurobindo Pharma Limited
12 1Chengdu Shengnuo Biopharm
13 1Conscientia Industrial
14 1Hangzhou Longshine Bio-Tech
15 2Hybio Pharmaceutical
16 1Jiangsu Sinopep Allsino Biopharmaceutical
17 1MSN Laboratories
18 1PolyPeptide Group
19 1Savior Lifetec Corporation
20 1ScinoPharm Taiwan, Ltd
21 1Smaart Pharmaceutticals
22 1Sun Pharmaceutical Industries Limited
23 1Blank
01 7China
02 8India
03 2Switzerland
04 2Taiwan
05 4U.S.A
06 1Blank
01 11Active
02 13Blank
01 24Blank
01 24Blank
01 24Blank
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
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-09-29
DMF Number : 38923
Submission : 2023-09-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-09-19
Pay. Date : 2018-08-13
DMF Number : 33079
Submission : 2018-08-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-03
Pay. Date : 2021-02-05
DMF Number : 35583
Submission : 2021-02-22
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-09
Pay. Date : 2019-05-17
DMF Number : 33857
Submission : 2019-05-19
Status : Active
Type : II
NDC Package Code : 52221-119
Start Marketing Date : 2017-06-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34713
Submission : 2020-09-01
Status : Active
Type : II
NDC Package Code : 69766-088
Start Marketing Date : 2020-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34388
Submission : 2019-12-31
Status : Active
Type : II
NDC Package Code : 14403-0013
Start Marketing Date : 2022-05-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-01-21
Pay. Date : 2021-12-22
DMF Number : 36502
Submission : 2021-12-29
Status : Active
Type : II
NDC Package Code : 14403-0013
Start Marketing Date : 2022-05-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-24
Pay. Date : 2019-05-16
DMF Number : 33210
Submission : 2019-01-01
Status : Active
Type : II
NDC Package Code : 65129-1312
Start Marketing Date : 2019-04-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-07-22
Pay. Date : 2019-06-17
DMF Number : 32144
Submission : 2019-02-04
Status : Active
Type : II
NDC Package Code : 59651-237
Start Marketing Date : 2023-12-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63557-0021
Start Marketing Date : 2021-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40036
Submission : 2024-05-30
Status : Active
Type : II
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Corporate PDF
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.
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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.
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