Register entry
Polypeptide Laboratories Private Ltd
Data as of · How to read this entry
- Registered sites
- 4
- Active NDC listings
- 20
- Labeller names
- 6
- Live patents
- 0
- Countries
- 4
- Base
- United States
Authorisation
Registered operations
Analytical testing4Active ingredient (API) manufacture4
Sites
Registered establishments
4| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| PolypeptideRegistrant: Polypeptide SA | Chaussee de Tubize 297, Braine-I'Alleud, 1420, Belgium (BEL) | Analytical testing, Active ingredient (API) manufacture | 3002808410763929036 |
| PolyPeptide Laboratories FranceRegistrant: Polypeptide Laboratories Inc | Technopole Du Rhin, 7 Rue de Boulogne, Strasbourg, - 67100, France (FRA) | Analytical testing, Active ingredient (API) manufacture | 3007417577634883672 |
| PolyPeptide Laboratories Private LimitedRegistrant: Polypeptide Laboratories Private Ltd | Plot No.K-28, Additional Midc Anand Nagar, Ambernath (East), Thane, Maharashtra 421506, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3009051788675939266 |
| Polypeptide Laboratories Inc | 365 Maple Ave, Torrance, California (CA) 90503-2602, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 1000519239962386124 |
Catalogue
Drug listings by form and route
2020 active NDC listings: 20 bulk ingredient. By marketing category: BULK INGREDIENT 20.
| Dosage form | NDCs |
|---|---|
| powder | 20 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| polypeptide laboratories inc | 7 |
| polypeptide laboratories france | 3 |
| polypeptide laboratories, pvt. ltd. | 3 |
| polypeptide sa | 3 |
| polypeptide laboratories private limited | 2 |
| polypeptide sa | 2 |
Catalogue
Marketed products
20| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | ABALOPARATIDE | powder | 68067-0399BULK INGREDIENT |
| - | COSYNTROPIN | powder | 63557-2071BULK INGREDIENT |
| - | Corticotropin | powder | 59149-005BULK INGREDIENT |
| - | DIFELIKEFALIN | powder | 59162-0002BULK INGREDIENT |
| - | Deslorelin | powder | 59149-003BULK INGREDIENT |
| - | ETEPLIRSEN | powder | 63557-2072BULK INGREDIENT |
| - | Exenatide | powder | 59149-004BULK INGREDIENT |
| - | Exenatide | powder | 68067-0397BULK INGREDIENT |
| - | Gonadorelin Hydrochloride | powder | 63557-2069BULK INGREDIENT |
| - | LIRAGLUTIDE | powder | 63557-2070BULK INGREDIENT |
| - | Leuprolide Acetate | powder | 59149-002BULK INGREDIENT |
| - | MACIMORELIN ACETATE | powder | 59162-0001BULK INGREDIENT |
| - | Octreotide Acetate | powder | 59149-007BULK INGREDIENT |
| - | SEMAGLUTIDE | powder | 68067-2602BULK INGREDIENT |
| - | SETMELANOTIDE ACETATE | powder | 68067-0398BULK INGREDIENT |
| - | Teduglutide | powder | 63557-1031BULK INGREDIENT |
| - | Teriparatide | powder | 63557-0021BULK INGREDIENT |
| - | ZILUCOPLAN | powder | 59162-0000BULK INGREDIENT |
| - | Zilucoplan | powder | 68067-0400BULK INGREDIENT |
| - | linaclotide | powder | 63557-0014BULK INGREDIENT |
Neighbours
Registered in the same town
12- Rubicon Research Canada LimitedThane, IND · 2 sites
- Zydus Lifesciences LimitedThane, IND
- Encube Ethicals LimitedThane, IND
- ALS Laboratories UK LimitedTorrance, CA
- Centaur Pharmaceuticals Private LimitedThane, IND
- AARTI PHARMALABS LIMITEDThane, IND
- Arch Pharmalabs LimitedThane, IND
- Supriya Lifescience LimitedThane, IND
- Bachem Americas, Inc.Torrance, CA
- COSMETIX WESTTorrance, CA
- ASCLEMED USA INC. DBA ENOVACHEMTorrance, CA
- ASolution Pharmaceuticals Pvt LtdThane, IND
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Enquiry
Common questions
- Is Polypeptide Laboratories Private Ltd FDA approved?
- Polypeptide Laboratories Private Ltd holds 4 FDA-registered establishments across 4 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Polypeptide Laboratories Private Ltd's drugs manufactured?
- At registered sites in Belgium, France, India, the United States. The FDA register lists Braine-I'Alleud; Strasbourg; Thane; Torrance, CA. Registered operations: analytical testing, active ingredient (API) manufacture.
- What drugs does Polypeptide Laboratories Private Ltd make?
- 20 products are listed under Polypeptide Laboratories Private Ltd in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.