B2B

FORMULATIONS
 OUR VISION
TO REACH 1.5 BILLION
PEOPLE ACROSS THE
GLOBE
Dr. Reddy’s API:
Dr. Reddy’s supplies high-quality APIs to leading formulation manufacturers across
the world, enabling them to develop affordable medicines for patients worldwide.
We are the preferred API partner to pharma companies across the US, Europe,
Latin America, Japan, China, Korea and emerging markets.

B2B Formulations:
To enable access to medicines in countries where we are not directly present,
we supply the finished products to our partners for them to distribute and
commercialize.

We offer market specific products and dossiers which meets the local requirements
in securing the marketing authorization followed by commercialization.
The products and dossiers can be customized as per country requirements.
Our Business Model:

Technology Transfer Pre-formulation Supply Formulation Supply

Activities at partner end: Activities at partner end: Activities at partner end:

• Analytical Method transfer • Analytical Method transfer • Filing
• Confirmatory Batch • Confirmatory Batch • Approval
• Exhibit batches • Exhibit batches
• Stability Studies • Stability Studies
• Bio study • Bio study
• Filing • Filing
• Approval • Approval

In addition to formulation, pre-formulation supplies and technology transfer, we

also focus on increasing our presence across:

A. Clinical Trial Supplies

i. Concise product list of oncology assets
ii. Regulatory approvals across the globe
iii. Single batch sourcing for global studies
iv. Optimised delivery timelines

B. Drug Shortages/Emergency supplies

i. Catering to patients affected with drug shortage
ii. Forecasting drug shortages
iii. Country specific regulatory licenses
iv. Shorter delivery lead time

Product Capabilities
1. R&D and Manufacturing Capabilities

Research and Manufacturing Niche Product Vertical

Development Facilities Opportunities Integration

4 State-of-the-art R&D 11 formulations Peptides, Prostaglandins, More than 60% of

centres in India, U.K., manufacturing facilities HPAPIs, Innovative our formulations are
U.S., and Netherlands drug delivery, Novel backward integrated
1200+ research dosage forms, Complex with our In-house API
scientists working on Injectables
various projects

Our 11 formulations manufacturing facilities that are operated in accordance with

cGMP (ICH Q7a) and regularly inspected/audited by international regulatory
authorities and customers (USFDA, MHRA, EMA, PMDA, TGA, SAHPRA, ANVISA,
Russian MoH, CFDA, COFEPRIS and Health Canada).
 2. Product Capabilities

Dr. Reddy’s has an expertise of developing and manufacturing various dosage

forms:

Oral Solids Injectables Novel Dosage Forms

Tablets, Chewable tablets, Oro- Lyophilized product and Liquid Emulsions, Suspensions,
dispersible tablets, Capsules, soft solution Microspheres Liposomes and
gel capsules Pellets and Granules Nanoparticles
(pre-formulation)

3. Service Capabilities

Highly experienced and integrated technical team to support from filing-to-launch.

Highly experienced technical and global regulatory teams with experience of 350+
Filings and 150+ approvals across B2B markets.

Regulatory services Tech Transfer support Bio Study design support

• Team of regulatory experts • Complete knowledge transfer • Clinical pharmacokinetic team

• Support filing activities • Support local manufacturing available
• Across multiple countries of • Design bio study protocol
interest

3. Global Presence

Europe
Turkey

Mexico MENA North Asia

Argentina
Finished Dosage Forms - Product List:
Dr. Reddy’s Laboratories is a leading API supplier, with a presence in over 80
countries and a portfolio of 200+ ANDA filings and approved dossiers. Our
offering goes beyond APIs and our global customers have access to high-quality
dossiers and finished dosage forms.

LEAD
THERAPY PRODUCT MARKET
ORAL INJ STRENGTH
AREA NAME DOSSIER
STATUS
Oncology Azacitidine ● 100 mg Filed
Oncology Bendamustine ● 25, 100 mg Filed
Bendamustine 45 mg/ml (4 ml)
Oncology ● Filed
RTD and 25 mg/ml (4 ml)
Oncology Bortezomib ● 3.5 mg Filed
Oncology Cabazitaxel ● 40 mg/ml (1.5 ml) Filed
Oncology Carfilzomib ● 60 mg Filed
Oncology Decitabine ● 50 mg Filed
Oncology Eribulin ● 0.5 mg/ml (2 ml) Filed
Oncology Fingolimod ● 0.5 mg Filed
Oncology Fulvestrant ● 50 mg/ml (5 ml) Filed
Liposomal
Oncology ● 2 mg/ml (10 ml and 25 ml) Filed
Doxorubicin
Oncology Palonosetron ● 0.075 mg/5 ml, 0.25 mg/ 5 ml Filed
Oncology Pemetrexed ● 100, 500, 1 gm Filed
Oncology Plerixafor ● 20 mg/ml (1.2 ml) Filed
Oncology Abiraterone* ● 250 mg, 500 mg Filed
Oncology Busulfan ● 6 mg/ml (10 ml) Filed
Oncology Capecitabine ● 150 mg, 500 mg Filed
Oncology Dasatinib ● 20, 50, 70, 80,100 and 140 mg Filed
Under
Oncology Enzalutamide ● 40 mg, 80 mg
development
Oncology Everolimus ● 2.5, 5, 7.5, 10 mg Filed
Oncology Lenalidomide* ● 2.5, 5, 10, 15, 20, 25 mg Filed
Under
Oncology Lenvatinib ● 4, 10 mg
development
Under
Oncology Nilotinib ● 50, 150, 200 mg
development

Disclaimer:
No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing
an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities
of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should
make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities.
Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.
Lead Market Dossier means Dossier submitted to SRA (Stringent Regulatory Authorities) markets
 LEAD
THERAPY PRODUCT MARKET
ORAL INJ STRENGTH
AREA NAME DOSSIER
STATUS
Oncology Palbociclib ● 75, 100, 125 mg Filed
Oncology Pomalidomide ● 1,2,3,4 mg Filed
Imatinib
Oncology ● 100 mg, 400 mg Filed
Mesylate
Oncology Carmustine ● 100 mg Filed
Oncology Venetoclax ● 10 mg, 50 mg and 100 mg Filed
Oncology Sorafenib ● 200 mg Filed
Oncology Midostaurin ● 25 mg Filed
Oncology Sunitinib Malate ● 12.5, 25, 37.5 and 50 mg Filed

Under
Oncology Nano Paclitaxel ● 100 mg
development

Under
Oncology Cabozantinib ● 20 mg, 40 mg and 60 mg
development
Under
Oncology Olaparib ● 100 mg and 150 mg
development
Under
Oncology Pazopanib ● 200 and 400 mg
development

Dimethyl Under
Oncology ● 120 mg, 240 mg
Fumarate Development

Under
Oncology Nintedanib ● 100 mg and 150 mg
Development
Oncology / Under
Octerotide ● 10 mg, 20 mg and 30 mg
Acromegaly Development
Oncology / 60 mg/0.2 ml, 90 mg/0.3 ml Under
Lanreotide ●
Acromegaly and 120 mg/0.5 ml Development

CNS Glatiramer ● 20, 40 mg Filed

CNS Edaravone ● 60 mg/100 ml Filed

CNS Sugammadex ● 100 mg/ml (2 ml and 5 ml) Filed

CNS Topiramate ER ● 25, 50, 100 and 200 mg Filed

2.5 mg/0.5 ml, 5 mg/0.4 ml,
CVD Fondaparinux ● Filed
7.5 mg/0.6 ml and 10 mg/0.8 ml
1 mg/ml, 2.5 mg/ml, 5 mg/ml
CVD Treprostinil ● Filed
and 10 mg/ml (20 ml)
CVD Apixaban* ● 2.5, 5 mg Filed
CVD Dabigatran* ● 75, 110, 150 mg Filed
CVD Rivaroxaban ● 10, 15, 20 mg Filed

Disclaimer:
No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing
an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities
of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should
make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities.
Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.
Lead Market Dossier means Dossier submitted to SRA (Stringent Regulatory Authorities) markets
 LEAD
THERAPY PRODUCT MARKET
ORAL INJ STRENGTH
AREA NAME DOSSIER
STATUS
Sacubitril/
CVD ● 24/26, 49/51, 97/103 mg Filed
Valsartan*
CVD Ticagrelor ● 60, 90 mg Filed
Tafamidis Under
CVD ● 20 mg
Meglumine Development
Under
CVD Edoxaban ● 15 mg, 30 mg, 60 mg
Development
Under
CVD Bempedoic acid ● 120 mg, 240 mg
Development

Bempedoic acid Under

CVD ● 180 mg/10 mg
Ezetimibe Development

Canagliflozin + 150 mg;1 g, 150 mg;500 mg, 50

Anti-Diabetic ● Filed
Metformin mg;1 g, 50 mg;500 mg
Anti-Diabetic Linagliptin ● 5 mg Filed
Linagliptin + 2.5 mg/500 mg, 2.5 mg/850
Anti-Diabetic ● Filed
Metformin mg, 2.5 mg/1 g
Anti-Diabetic Sitagliptin HCL ● 25, 50, 100 mg Filed
Sitagliptin
Anti-Diabetic ● 25, 50, 100 mg Filed
Phosphate

Sitagliptin HCL + Under

Anti-Diabetic ● 50 + 500, 50 + 850,
Metformin Development

Sitagliptin
Anti-Diabetic Phosphate + ● 50 + 500, 50 + 1000 mg Filed
Metformin
Under
Anti-Diabetic Liraglutide ● 6 mg/ml (3 ml)
development
Anti-Diabetic Semaglutide ● 1.34 mg/ml (1.5 ml and 3 ml) Filed
Under
Anti-Obesity Liraglutide ● 6 mg/ml (3 ml)
development
GI Esomeprazole ● 20, 40 mg Filed
Esomeprazole
GI MG + Naproxen ● 20 mg/375 mg, 20 mg/500 mg Filed
Na
Lansoprazole
GI ● 15 mg and 30 mg Filed
ODT
Immuno
Sirolimus ● 1 mg and 2 mg Filed
suppressant

Disclaimer:
No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing
an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities
of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should
make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities.
Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.
Lead Market Dossier means Dossier submitted to SRA (Stringent Regulatory Authorities) markets
 LEAD
THERAPY PRODUCT MARKET
ORAL INJ STRENGTH
AREA NAME DOSSIER
STATUS
Immuno
Tacrolimus ● 0.5 mg, 1 mg and 5 mg Filed
suppressant
Others Daptomycin ● 350, 500 mg Filed
100 mg/5 ml,200 mg/10 ml, 50
Others Iron Sucrose ● Filed
mg/2.5 ml
Others Apremilast ● 10, 20, 30 mg Filed

Sevelamer
Others ● 800 mg Filed
Carbonate

Others Valganciclovir ● 450 mg Filed

Others Isotretinoin ● 10 mg, 20 mg, 30 mg and 40 mg Filed
Others Posaconazole ● 100 mg Filed
Naproxen
Others ● 275 mg, 550 mg Filed
Sodium *
Ferric Carboxy 50 mg/ml (2 ml, 10 ml, 15 ml Under
Others ●
Maltose and 20ml) Development

Others Teriparatide ● 0.25 mg/ml (2.4 ml) Filed

Under
Others Amphotericin B ● 50 mg
Development
Under
Others Mesalamine ● 250 and 500 mg
Development
Under
Others Tofacitinib XR ● 22 mg
development

*We also offer preformulations for the selected products.

Disclaimer:
No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing
an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities
of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should
make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities.
Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.
Lead Market Dossier means Dossier submitted to SRA (Stringent Regulatory Authorities) markets
Products for Clinical trials

US EU
THERAPY DOSAGE
PRODUCT NAME APPROVAL APPROVAL
AREA FORM
STATUS STATUS
Doxorubicin Hydrochloride Liposome
Oncology Injection, 20 mg/10 ml (2 mg/ml) and Injection Approved Under review
50 mg/25 ml (2 mg/ml) Single-dose Vials

Oncology Imatinib Mesylate Tablets 100/400 mg Tablets Approved NA

Imatinib Mesylate Capsules

Oncology Capsules NA Approved
50/100/400 mg
Docetaxel Injection Concentrate
Oncology Injection Approved Approved
and 80 mg/4 ml
Bendamustine HCl Concentrate for
Oncology Infusion NA Approved
Solution for Infusion 180 mg_4 ml
Bendamustine Hydrochloride Injection Tentative
Oncology Injection NA
25 mg/Vial and 100 mg/Vial Approved

Oncology Capecitabine Tablets 500 mg Tablets Approved Approved

Oncology Capecitabine Tablets 150 mg Tablets Approved NA

Fulvestrant Injection 250 mg/5 ml

Oncology Injection Approved Approved
(50 mg/ml)
Dasatinib 20 mg, 50 mg, 70 mg, 80 mg, Tentative
Oncology Tablets Under Review
100 mg, 140 mg Film tablet Approved

Oncology Bortezomib For Injection 3.5 mg/vial Injection Approved Approved

Oncology Decitabine for Injection 50 mglVial Injection Approved NA

Oncology Azacitidine for Inj 100 mg/vial Injection Approved Approved

Approved
(2.5, 20 mg)
Lenalidomide Capsules 2.5 mg, 5 mg,
Oncology Capsules Tentative NA
10 mg, 15 mg, 20 mg and 25 mg approved
(Other SKUs)
Pemetrexed, 100 mg, 500 mg, powder
Tentative
Oncology for concentrate for solution for infusion Infusion Approved
Approved
(Di Sodium Amorphous)
Pemetrexed for Injection 100 mg/Vial, Tentative
Oncology Injection NA
500 mg/Vial, 1g/vial Approved
 US EU
THERAPY DOSAGE
PRODUCT NAME APPROVAL APPROVAL
AREA FORM
STATUS STATUS
Pomalidomide Capsules Tentative
Oncology Capsules NA
1 mg, 2 mg, 3 mg and 4 mg Approved

Oncology Carfilzomib for Injection 60 mg/vial Injection Approved NA

Palbociclib Capsules, 75 mg, 100 mg Tentative

Oncology Capsules NA
and 125 mg Approved

Oncology Abiraterone Acetate Tablets 250 mg Tablets Approved NA

Melphalan Hydrochloride for Injection,

Oncology Injection Approved NA
50 mg Single-Dose Vial

Oncology Cabazitaxel Injection 60 mg/1.5 ml Injection Approved Approved

Oncology Sunitinib Malate Capsules Approved NA

Immuno Tacrolimus Capsules, 0.5 mg, 1 mg

Capsules Approved NA
suppressant and 5 mg
Immuno
Sirolimus 1 mg and 2 mg Tablets Approved NA
suppressant