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

Products Offered Commerically

PRODUCTS AVAILABLETHERAPEUTIC USAGECAS NO.DMF AVAILABLE
AdapaleneAcne treatment106685-40-9cos
Amiloride HCLDiuretic17440-83-4DMF
AripiprazoleAntipsychotic129722-12-9TDP
Bepotastine besylateAntihistamine190786-44-8DMF
Benzydamine HCLAntiinflammatory132-69-4DMF
BilastineAntihistamine202189-78-4TDP
DeferasiroxIronChelator201530-41-8TDP
EbastineAntihistamine90729-43-4cos
Epinastine HCLAntihistamine108929-04-0DMF
EtizolamAnxiolytic40054-69-1TDP
GliclazideAntidiabetic21187-98-4cos
MizolastineAntihistamine108612-45-9TDP
PaliperidoneAntipsychotic144598-75-4DMF
Paliperidone palmitateAntipsychotic199739-10-1TDP
Prazosin HCLAntihypertensive19237-84-4TDP
PyrimethamineAntiparasitic58-14-0TDP
TeneligliptinAntidiabetic760937-92-6TDP
Tolterodine tartrateUrinary incontinence124937-52-6DMF
TopiramateAnticonvulsant97240-79-4DMF
TriamtereneDiuretic396-01-0TDP
Trientine HCLWilson's disease38260-01-4DMF

Products Under Scale UP

PRODUCTS AVAILABLETHERAPEUTIC USAGECAS NO.
AlbendazoleAnthelmintic54965-21-8
Alfuzosin HCLAntihypertensive81403-68-1
BaclofenMuscle relaxant1134-47-0
BosentanAntihypertensive147536-97-8
Dabigatran Etexilate MesylateAntithrambotic872728-81-9
MirabegronOveractive bladder223673-61-8
Ropinirole HCLParkinson's disease91374-20-8
Terazosin HCLAntihypertensive70024-40-7

Products Under R&D

PRODUCTS AVAILABLETHERAPEUTIC USAGECAS NO.
Cinacalce tHCLAntihyperparathyroid364782-34-3
Esomeprazole MagnesiumGastroesophageal relux disease{GERO)217087-09-7
Levocloperastine FendizoateAntitussive220329-19-1
TicagrelorPlatelet Aggregation Inhibitor274693-27-5
VildagliptinAntidiabetic274901-16-5
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