Register entryShortage reported
Sun Pharmaceutical Industries Limited
- Registered sites
- 13
- Drug products
- 913
- Live patents
- 110
- Countries
- 2
- Base
- India
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingRepackaging
Sites
Facilities
13| Site | Location | Operations | FEI |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | AhilyanagarIndia | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3003227153 |
| Sun Pharmaceutical Industries Limited | AnkleshwarIndia | Analytical testing, Active ingredient (API) manufacture | 3012032037 |
| Sun Pharmaceutical Industries Limited | BharuchIndia | Analytical testing, Active ingredient (API) manufacture | 3010027135 |
| Sun Pharmaceutical Industries Limited | BharuchIndia | Analytical testing, Active ingredient (API) manufacture | 3003952717 |
| Sun Pharmaceutical Industries Limited | ChengalpattuIndia | Analytical testing, Active ingredient (API) manufacture | 3007627683 |
| Sun Pharmaceutical Industries Limited | DadraIndia | Analytical testing, Finished drug manufacture | 3004561553 |
| Sun Pharmaceutical Industries Limited | GurugramIndia | Analytical testing | 3002871444 |
| Sun Pharmaceutical Industries Limited | HalolIndia | Analytical testing, Finished drug manufacture | 3002809586 |
| Sun Pharmaceutical Industries Limited | MohaliIndia | Analytical testing, Finished drug manufacture | 3002807979 |
| Sun Pharmaceutical Industries Limited | New DelhiIndia | Analytical testing | 3003892973 |
| Sun Pharmaceutical Industries Limited | VadodaraIndia | Analytical testing | 3004520113 |
| Sun Pharmaceutical Industries, Inc. | Billerica, MAUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3009395771 |
| Ohm Laboratories Inc. | North Brunswick, NJUnited States | Analytical testing, Finished drug manufacture, Packaging, Repackaging | 3004132058 |
Alert
Products in shortage
19| Drug | Presentation | Availability |
|---|---|---|
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 57664-048-88) | Limited Availability |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 57664-048-88) | Limited Availability |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 57664-050-88) | Limited Availability |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 57664-051-88) | Limited Availability |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 57664-049-88) | Limited Availability |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 57664-046-88) | Limited Availability |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 57664-052-88) | Limited Availability |
| Lisdexamfetamine Dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate, Tablet, Chewable, 40 mg (NDC 57664-086-88) | Available |
| Lisdexamfetamine Dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate, Tablet, Chewable, 60 mg (NDC 57664-088-88) | Available |
| Lisdexamfetamine Dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate, Tablet, Chewable, 30 mg (NDC 57664-085-88) | Available |
| Lisdexamfetamine Dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate, Tablet, Chewable, 20 mg (NDC 57664-084-88) | Available |
| Lisdexamfetamine Dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate, Tablet, Chewable, 10 mg (NDC 57664-083-88) | Available |
| Lisdexamfetamine Dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate, Tablet, Chewable, 50 mg (NDC 57664-087-88) | Available |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 57664-609-88) | Unavailable |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 57664-608-88) | Unavailable |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 57664-607-88) | Unavailable |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 57664-606-88) | Unavailable |
| Technetium TC-99M Pyrophosphate Kit Injection | CIS-PYRO, Injection, 12 mg/10 mL (NDC 45567-0060-2) | Unavailable |
| Technetium TC-99M Pyrophosphate Kit Injection | CIS-PYRO, Injection, 12 mg/10 mL (NDC 45567-0060-1) | Unavailable |
Exclusivity
Patents
110Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ABSORICA LD | ISOTRETINOIN | May 2035 |
| ABSORICA LD | ISOTRETINOIN | Aug 2035 |
| ASPRUZYO SPRINKLE | RANOLAZINE | Jan 2038 |
| BROMSITE | BROMFENAC SODIUM | Mar 2029 |
| BYNFEZIA PEN | OCTREOTIDE ACETATE | May 2038 |
| BYNFEZIA PEN | OCTREOTIDE ACETATE | Nov 2040 |
| BYNFEZIA PEN | OCTREOTIDE ACETATE | Dec 2041 |
| CEQUA | CYCLOSPORINE | Aug 2033 |
| CEQUA | CYCLOSPORINE | Feb 2037 |
| DRIZALMA SPRINKLE | DULOXETINE HYDROCHLORIDE | Apr 2037 |
| EZALLOR SPRINKLE | ROSUVASTATIN CALCIUM | Feb 2036 |
| FLO-PRED | PREDNISOLONE ACETATE | Oct 2028 |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | Jul 2033 |
| KAPSPARGO SPRINKLE | METOPROLOL SUCCINATE | Jul 2035 |
| LEQSELVI | DEURUXOLITINIB PHOSPHATE | May 2037 |
| LEQSELVI | DEURUXOLITINIB PHOSPHATE | May 2041 |
| LEQSELVI | DEURUXOLITINIB PHOSPHATE | Aug 2042 |
| LEQSELVI | DEURUXOLITINIB PHOSPHATE | May 2044 |
| LEQSELVI | DEURUXOLITINIB PHOSPHATE | Oct 2044 |
| LEVULAN | AMINOLEVULINIC ACID HYDROCHLORIDE | Oct 2036 |
| LEVULAN | AMINOLEVULINIC ACID HYDROCHLORIDE | Jan 2037 |
| LEVULAN | AMINOLEVULINIC ACID HYDROCHLORIDE | Jan 2038 |
| ODOMZO | SONIDEGIB PHOSPHATE | Jul 2029 |
| ODOMZO | SONIDEGIB PHOSPHATE | Sept 2029 |
| ODOMZO | SONIDEGIB PHOSPHATE | Mar 2036 |
| ORTIKOS | BUDESONIDE | Sept 2036 |
| RIOMET ER | METFORMIN HYDROCHLORIDE | May 2035 |
| SEZABY | PHENOBARBITAL SODIUM | Apr 2042 |
| TOPICORT | DESOXIMETASONE | Sept 2028 |
| WINLEVI | CLASCOTERONE | Jan 2027 |
| WINLEVI | CLASCOTERONE | Jul 2028 |
| WINLEVI | CLASCOTERONE | Aug 2028 |
| WINLEVI | CLASCOTERONE | Nov 2028 |
| WINLEVI | CLASCOTERONE | Feb 2029 |
| WINLEVI | CLASCOTERONE | Jul 2030 |
| XELPROS | LATANOPROST | Oct 2028 |
| XELPROS | LATANOPROST | Sept 2029 |
| YONSA | ABIRATERONE ACETATE | Mar 2034 |
| YONSA | ABIRATERONE ACETATE | May 2034 |
Catalogue
Marketed products
913Showing 150 of 913.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ADAPALENE and BENZOYL PEROXIDE | ADAPALENE and BENZOYL PEROXIDE | GEL | ANDA |
| ASPRUZYO SPRINKLE | Ranolazine | GRANULE | NDA |
| - | Abiraterone Acetate | POWDER | BULK INGREDIENT |
| Absorica | isotretinoin | CAPSULE | NDA |
| Absorica | isotretinoin | CAPSULE | NDA |
| Absorica | isotretinoin | CAPSULE | NDA |
| Absorica | isotretinoin | CAPSULE | NDA |
| Absorica | isotretinoin | CAPSULE | NDA |
| Absorica | isotretinoin | CAPSULE | NDA |
| Absorica LD | isotretinoin | CAPSULE | NDA |
| Absorica LD | isotretinoin | CAPSULE | NDA |
| Absorica LD | isotretinoin | CAPSULE | NDA |
| Absorica LD | isotretinoin | CAPSULE | NDA |
| Acetaminophen 250 mg and Ibuprofen 125 mg | Acetaminophen 250 mg and Ibuprofen 125 mg Tablets | TABLET | ANDA |
| - | Acitretin | POWDER | BULK INGREDIENT |
| Acyclovir | Acyclovir | OINTMENT | ANDA |
| Acyclovir | Acyclovir | CREAM | ANDA |
| Adapalene | Adapalene | GEL | ANDA |
| Adapalene | Adapalene | GEL | ANDA |
| Adapalene and Benzoyl Peroxide | ADAPALENE and BENZOYL PEROXIDE | GEL | ANDA |
| - | Afatinib Dimaleate | POWDER | BULK INGREDIENT |
| AfterPlan | levonorgestrel | TABLET | ANDA |
| Albuterol Sulfate | albuterol sulfate | SOLUTION | ANDA |
| Alclometasone Dipropionate | Alclometasone dipropionate | OINTMENT | ANDA |
| Alclometasone dipropionate | Alclometasone dipropionate | CREAM | ANDA |
| - | Alectinib Hydrochloride | POWDER | BULK INGREDIENT |
| - | Alendronate Sodium | POWDER | BULK INGREDIENT |
| Alfuzosin Hydrochloride | Alfuzosin Hydrochloride | TABLET, EXTENDED RELEASE | ANDA |
| Allopurinol | Allopurinol | TABLET | ANDA |
| Allopurinol | Allopurinol | TABLET | ANDA |
| Amcinonide | Amcinonide | OINTMENT | ANDA |
| - | Amifostine | POWDER | BULK INGREDIENT |
| Amiodarone Hydrochloride | Amiodarone Hydrochloride | TABLET | ANDA |
| Amiodarone Hydrochloride | Amiodarone Hydrochloride | TABLET | ANDA |
| Amiodarone Hydrochloride | Amiodarone Hydrochloride | TABLET | ANDA |
| Amiodarone Hydrochloride | Amiodarone Hydrochloride | TABLET | ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | TABLET, FILM COATED | ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | TABLET, FILM COATED | ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | TABLET, FILM COATED | ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | TABLET, FILM COATED | ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | TABLET, FILM COATED | ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | TABLET, FILM COATED | ANDA |
| Ammonium Lactate | Ammonium Lactate | LOTION | ANDA |
| Ammonium Lactate | Ammonium Lactate | CREAM | ANDA |
| Amphotericin B | Amphotericin B | INJECTABLE, LIPOSOMAL | ANDA |
| Amphotericin B | Amphotericin B | INJECTABLE, LIPOSOMAL | ANDA |
| - | Apremilast | POWDER | BULK INGREDIENT |
| Arformoterol Tartrate | Arformoterol Tartrate | SOLUTION | ANDA |
| - | Aripiprazole | POWDER | BULK INGREDIENT |
| - | Asenapine Maleate | POWDER | BULK INGREDIENT |
| Athletes Foot | Butenafine Hydrochloride | CREAM | ANDA |
| Atorvastatin Calcium | Atorvastatin Calcium | TABLET, FILM COATED | ANDA |
| Atorvastatin Calcium | Atorvastatin Calcium | TABLET, FILM COATED | ANDA |
| - | Atorvastatin Calcium Trihydrate | POWDER | BULK INGREDIENT |
| - | Azacitidine | POWDER | BULK INGREDIENT |
| Azelaic Acid | Azelaic Acid | GEL | ANDA |
| Azelastine Hydrochloride | Azelastine Hydrochloride | SPRAY, METERED | ANDA |
| Azelastine Hydrochloride | Azelastine Hydrochloride | SOLUTION/ DROPS | ANDA |
| Azithromycin | Azithromycin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Azithromycin monohydrate | Azithromycin monohydrate | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| BETAMETHASONE VALERATE | Betamethasone Valerate | CREAM | ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | TABLET, FILM COATED | ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | TABLET, FILM COATED | ANDA |
| BROMSITE 0.075% | bromfenac | SOLUTION/ DROPS | NDA |
| BYNFEZIA Pen | octreotide acetate | INJECTION | NDA |
| Bacitracin Zinc | Bacitracin Zinc | OINTMENT | OTC MONOGRAPH DRUG |
| Bactrim | sulfamethoxazole and Trimethoprim | TABLET | NDA |
| Bactrim DS | sulfamethoxazole and Trimethoprim | TABLET | NDA |
| - | Bendamustine hydrochloride | POWDER | BULK INGREDIENT |
| Betamethasone Dipropionate | Betamethasone Dipropionate | CREAM | ANDA |
| Betamethasone Dipropionate | Betamethasone Dipropionate | GEL | ANDA |
| Betamethasone Dipropionate | Betamethasone Dipropionate | CREAM, AUGMENTED | ANDA |
| Betamethasone Dipropionate | Betamethasone Dipropionate | LOTION, AUGMENTED | ANDA |
| Betamethasone Valerate | Betamethasone Valerate | AEROSOL, FOAM | ANDA |
| Betamethasone dipropionate | Betamethasone dipropionate | SPRAY | ANDA |
| - | Bicalutamide | POWDER | BULK INGREDIENT |
| - | Bivalirudin | POWDER | BULK INGREDIENT |
| - | Bortezomib | POWDER | BULK INGREDIENT |
| Bosentan | Bosentan | TABLET, FILM COATED | ANDA |
| Bosentan | Bosentan | TABLET, FILM COATED | ANDA |
| - | Bosentan Monohydrate | POWDER | BULK INGREDIENT |
| - | Bosutinib | POWDER | BULK INGREDIENT |
| Budesonide | Budesonide | SUSPENSION | ANDA |
| Budesonide | Budesonide | SUSPENSION | ANDA |
| Budesonide | Budesonide | SUSPENSION | ANDA |
| - | Budesonide | POWDER | BULK INGREDIENT |
| Bumetanide | Bumetanide | TABLET | ANDA |
| Bumetanide | Bumetanide | TABLET | ANDA |
| Bumetanide | Bumetanide | TABLET | ANDA |
| - | Buprenorphine | POWDER | BULK INGREDIENT |
| Buprenorphine | Buprenorphine | TABLET | ANDA |
| Buprenorphine | Buprenorphine | TABLET | ANDA |
| - | Buprenorphine Base | POWDER | BULK INGREDIENT |
| - | Buprenorphine Hydrochloride | POWDER | BULK INGREDIENT |
| Buprenorphine and Naloxone | Buprenorphine and Naloxone | TABLET | ANDA |
| Buprenorphine and Naloxone | Buprenorphine and Naloxone | TABLET | ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | TABLET, EXTENDED RELEASE | ANDA |
| - | Bupropion Hydrochloride | POWDER | BULK INGREDIENT |
| Bupropion hydrochloride | Bupropion hydrochloride | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Bupropion hydrochloride | Bupropion hydrochloride | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Bupropion hydrochloride | Bupropion hydrochloride | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Butalbital, Acetaminophen and Caffeine | butalbital, acetaminophen, and caffeine | CAPSULE | ANDA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | TABLET, ORALLY DISINTEGRATING | ANDA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | TABLET, ORALLY DISINTEGRATING | ANDA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | TABLET, ORALLY DISINTEGRATING | ANDA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | TABLET, EXTENDED RELEASE | ANDA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | TABLET, EXTENDED RELEASE | ANDA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | TABLET | ANDA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | TABLET | ANDA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | TABLET | ANDA |
| CEQUA | cyclosporine | SOLUTION/ DROPS | NDA |
| CEQUA | cyclosporine | SOLUTION/ DROPS | NDA |
| CHLOROTHIAZIDE SODIUM | CHLOROTHIAZIDE SODIUM | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| CLOMIPRAMINE HYDROCHLORIDE | Clomipramine Hydrochloride | CAPSULE | ANDA |
| CLOMIPRAMINE HYDROCHLORIDE | Clomipramine Hydrochloride | CAPSULE | ANDA |
| CLOMIPRAMINE HYDROCHLORIDE | Clomipramine Hydrochloride | CAPSULE | ANDA |
| Caffeine Citrate | Caffeine Citrate | INJECTION | ANDA |
| Caffeine Citrate | Caffeine Citrate | SOLUTION | ANDA |
| Calcipotriene | Calcipotriene | OINTMENT | ANDA |
| Calcipotriene and Betamethasone Dipropionate | Calcipotriene and Betamethasone Dipropionate | SUSPENSION | ANDA |
| Calcitrene | Calcipotriene | OINTMENT | ANDA |
| Calcitriol | Calcitriol | CAPSULE, LIQUID FILLED | ANDA |
| Calcitriol | Calcitriol | CAPSULE, LIQUID FILLED | ANDA |
| - | Canagliflozin crystalline | POWDER | BULK INGREDIENT |
| - | Capecitabine | POWDER | BULK INGREDIENT |
| Capecitabine | Capecitabine | TABLET, FILM COATED | ANDA |
| Capecitabine | Capecitabine | TABLET, FILM COATED | ANDA |
| Carbamazepine | Carbamazepine | TABLET | ANDA |
| Carbamazepine | Carbamazepine | TABLET, CHEWABLE | ANDA |
| Carbamazepine | Carbamazepine | SUSPENSION | ANDA |
| Carbamazepine | Carbamazepine | TABLET, CHEWABLE | ANDA |
| Carbamazepine | Carbamazepine | TABLET, EXTENDED RELEASE | ANDA |
| Carbamazepine | Carbamazepine | TABLET, EXTENDED RELEASE | ANDA |
| Carbamazepine | Carbamazepine | TABLET, EXTENDED RELEASE | ANDA |
| - | Carboplatin | POWDER | BULK INGREDIENT |
| - | Cariprazine Hydrochloride | POWDER | BULK INGREDIENT |
| - | Carisoprodol | POWDER | BULK INGREDIENT |
| - | Carvedilol | POWDER | BULK INGREDIENT |
| Carvedilol Phosphate | Carvedilol Phosphate | CAPSULE, EXTENDED RELEASE | ANDA |
| Carvedilol Phosphate | Carvedilol Phosphate | CAPSULE, EXTENDED RELEASE | ANDA |
| Carvedilol Phosphate | Carvedilol Phosphate | CAPSULE, EXTENDED RELEASE | ANDA |
| Carvedilol Phosphate | Carvedilol Phosphate | CAPSULE, EXTENDED RELEASE | ANDA |
| - | Cetirizine Dihydrochloride | POWDER | BULK INGREDIENT |
| Cetirizine Hydrochloride | Cetirizine Hydrochloride | SOLUTION | ANDA |
| Cetirizine Hydrochloride | Cetirizine Hydrochloride | SOLUTION | ANDA |
| Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Cevimeline | Cevimeline | CAPSULE | NDA |
| Childrens Cetirizine Hydrochloride | Cetirizine Hydrochloride | SOLUTION | ANDA |
| Childrens Cetirizine Hydrochloride Sugar Free Grape | Cetirizine Hydrochloride | SOLUTION | ANDA |
| Childrens Fexofenadine Hydrochloride Allergy | FEXOFENADINE HYDROCHLORIDE | SUSPENSION | ANDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.