The United States Food and Drug Administration (USFDA) approved more Abbreviated New Drug Application (ANDA) in 2017 than any other year, according to its latest FY 2017 activities report9.
An ANDA contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use10.
The USFDA approved total 84711 ANDA during 2017 which is the highest number of ANDA approvals during the last decade. Indian Pharmaceutical companies along with their combined global subsidiaries have received a total of 314 final ANDA amounting to 37% of total approvals from the USFDA in the year 2017.
Amongst the Indian pharmaceutical companies, the Zydus group and its subsidiaries secured 77 approvals, the highest number of ANDA approvals received in 2017. The Zydus group is followed by Aurobindo Pharma (51), Sun Pharma (22) Glenmark Pharmaceutical (18), Lupin (17), Gland Pharma (16), Alkem Laboratories (15), Macleods Pharma (15), Cipla (10) and Dr Reddy's (10).
The table below represents all final ANDA approvals by the Indian pharmaceutical companies:
| Name of the Company | Number of final ANDA Approvals |
| ZYDUS GROUP | 77 |
| AUROBINDO PHARMA | 51 |
| SUN PHARMA GROUP | 22 |
| GLENMARK PHARMA | 18 |
| LUPIN | 17 |
| GLAND PHARMA | 16 |
| MACLEODS PHARMA | 15 |
| ALKEM LABS | 15 |
| CIPLA LTD | 10 |
| DR REDDYS | 10 |
| STRIDES PHARMA | 9 |
| ALEMBIC PHARMA | 9 |
| JUBILANT GENERICS | 7 |
| AJANTA PHARMA | 6 |
| MICRO LABS | 6 |
| UNICHEM LABS | 5 |
| WOCKHARDT | 5 |
| MSN LABS | 3 |
| TORRENT PHARMA | 3 |
| NATCO PHARMA | 2 |
| PANACEA BIOTEC | 2 |
| ORCHID HLTHCARE | 2 |
| MARKSANS PHARMA | 1 |
| INTAS PHARMA | 1 |
| HETERO LABS | 1 |
| GRANULES INDIA | 1 |
| Total | 314 |
The Graph below shows final ANDA Approvals received by the Indian Pharmaceutical Manufacturers and their subsidiaries.
Further, the FDA tentatively approved 175 applications. According to the US FDA, a tentative approval is issued to the applicant when the application is approvable prior to the expiration of any patents or exclusivities accorded to the reference listed drug product. A tentative approval does not allow the applicant to market the generic drug product and postpones the final approval until all patent/exclusivity issues have expired. First Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace12.
Out of these 175 tentative approvals by the FDA13, the Indian Pharmaceutical companies and their subsidiaries managed to secure 66 tentative approvals from the agency in 2017. The highest number of tentative approvals was secured by the Aurobindo group (11), followed by Sun Pharma (09), Zydus (08), Cipla (07), and Alembic Pharma, and Glenmark Pharma with 05 approvals each.
The table below represents all tentative ANDA approvals by the Indian pharmaceutical companies:
| Name of the Company | Number of Tentative ANDA Approvals |
| AUROBINDO PHARMA LTD | 11 |
| SUN PHARMA | 9 |
| ZYDUS PHARMA | 8 |
| CIPLA | 7 |
| ALEMBIC PHARMS LTD | 5 |
| GLENMARK PHARMA | 5 |
| HETERO DRUGS | 4 |
| MICRO LABS LTD | 2 |
| WOCKHARDT | 2 |
| TORRENT PHARMA | 2 |
| DR REDDYS | 2 |
| AJANTA PHARMA LTD | 1 |
| ALKEM LABS LTD | 1 |
| BIOCON LIMITED | 1 |
| GLAND PHARMA LTD | 1 |
| LAURUS LABS PRIVATE LTD | 1 |
| LUPIN LTD | 1 |
| MACLEODS PHARMS LTD | 1 |
| MSN LABS PVT LTD | 1 |
| STRIDES PHARMA | 1 |
| Total | 66 |
Other Indian Pharmaceutical companies that received tentative approvals from the US FDA are Hetero, Micro labs, Wockhardt, Torrent, Dr Reddys, Ajanta pharma, Alkem labs, Biocon, Gland pharma, Laurus labs, Lupin, Macleods, MSN labs, and Strides Pharma.
Conclusion:
The Indian Pharmaceutical Manufacturers had a splendid year at US FDA where they managed to secure the highest number of final and tentative ANDA approvals from the agency. This record ANDA approvals for the Indian manufacturers should also translate into higher revenues for them once they start marketing their approved generic products in the United States.
Footnotes
11. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
13. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
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