International

API Active Pharmaceutical Ingredients

Bal Pharma API (Active Pharmaceutical Ingredients) business began in 1996 with a simple objective of facilitating the manufacture of niche molecules that have been able to take the benefits of vertical integration to international and domestic markets.

Bal Pharma’s API business has the competence and knowledge to undertake more than 30 different types of complex chemical reactions. Whether these are Advance Intermediates, Fine Chemicals or Active Pharmaceuticals Ingredients, the company can seamlessly scale up from MG to MT quantities. It offers various activities like:


  State-of-the-art Pilot and Commercial Scale multipurpose facilities

  Pharmaceutical Manufacturing Plants conforming to GMP guidelines

  R & D facilities to support early development of Generic APIs

  Patent non-infringing processes

  High quality documents – Drug master file



The API products are being exported to Japan, Australia, Spain, UK, Canada, Nigeria, Iceland, Slovenia, Romania, Argentina, Brazil, Pakistan, Germany, South Africa, Serbia, Taiwan, Malaysia, Thailand, Turkey, Egypt, Korea, Venezuela, Italy, Portugal, Morocco, Poland, Netherlands, Syria, Bangladesh and Indonesia etc.

The range of APIs includes Anti-Histamine, Platelet Inhibitor, Anti-Diabetic, Anti Convulsant, Urinary Incontinence, Neuropathic Pain, Anti Allergy, Anti Inflammatory, Diuretic, Acne Treatment etc.

The plant has various accreditations.


Certification

ISO 9001: 2015 Annex ISO 9001: 2015 Approval from EDQM for Gliclazide
Ministry of Food & drug Safety Korea Gliclazide Ministry of Food & drug Safety Korea Ebastine COFEPRIS, MEXICO approval for Benzydamine HCl, Ebastine and Tolterodine tartrate
ANSM France, Health Canada, WHO GMP Only Indian company to be granted a COS for Gliclazide One of the first Indian companies to successfully file and receive approval by MHLW Japan
TGA approval for Gliclazide ANVISA GMP First Indian company to file US DMF for Bepotastine Besilate

Products Offered Commerically

PRODUCTSTHERAPEUTIC USAGECAS NO.DMF AVAILABLE
AdapaleneAcne treatment106685-40-9CEP
Alfuzosin HCLAntihypertensive81403-68-1DMF
Amiloride HCLDiuretic17440-83-4CEP
AripiprazoleAntipsychotic129722-12-9CEP Filed
BaclofenMuscle relaxant1134-47-0CEP Filing Q4-2025
Bepotastine besilateAntihistamine190786-44-8USDMF
Benzydamine HCLAntiinflammatory132-69-4CEP
Dabigatran Etexilate MesylateAntithrombotic872728-81-9CEP Filed
DeferasiroxIron Chelator201530-41-8CEP Filed
EbastineAntihistamine90729-43-4CEP
Epinastine HCLAntihistamine108929-04-0DMF
GliclazideAntidiabetic21187-98-4CEP
Levobunolol HCLBeta-adrenergic antagonist27912-14-7TDP
PaliperidoneAntipsychotic144598-75-4DMF
Prazosin HCLAntihypertensive19237-84-4DMF
Tolterodine tartrateUrinary incontinence124937-52-6DMF
TopiramateAnticonvulsant97240-79-4CEP Filing Q4-2025
VildagliptinAntidiabetic274901-16-5TDP

Products Under Scale UP

PRODUCTSTHERAPEUTIC USAGECAS NO.
BilastineAntihistamine 202189-78-4
DapagliflozinAntidiabetic461432-26-8
EmpagliflozinAntidiabetic864070-44-0
HydrochlorothiazideDiuretic58-93-5
PyrimethamineAntiparasitic58-14-0

Products Under R&D

PRODUCTSTHERAPEUTIC USAGECAS NO.
ApixabanAnticoagulants503612-47-3
CanagliflozinAntidiabetic842133-18-0
Cinacalcet HCLAntihyperparathyroid364782-34-3
DesloratadineAntihistamine100643-71-8
MirabegronOveractive bladder223673-61-8
RivaroxabanAnticoagulants366789-02-8
SemaglutideAntidiabetic910463-68-2
Sitagliptin PhosphateAntidiabetic654671-78-0
SulfadoxineAntimalarial2447-57-6
DexlansoprazoleProton pump inhibitors138530-94-6
Atomoxetine HCLSerotonin-Norepinephrine Reuptake Inhibitor (SNRI)82248-59-7
Duloxetine HCLSerotonin-Norepinephrine Reuptake Inhibitor (SNRI)136434-34-9
Rosuvastatin CalciumLipid-lowering agents (HMG-CoA reductase inhibitors)147098-20-2
Download API Product list Download API Intermediate List